We have published a cautionary article by Moorfields’ Ken Pullum on this topic. Read it at https://www.keratoconus-group.org.uk/index.php/implantable-contact-lenses/.
VOLUNTARY RECALL OF CERTAIN LOTS OF CONTACT LENS SOLUTIONS, EYE WASH AND EYE LUBRICANTS
No Known Safety Concerns Related to this Recall – This information has been coped from the Bausch & Lomb website. More information can be found on the Which Website. Also comments from our members about alternative products on our Discussion Forum. If in doubt, contact your optometrist.
Click here to verify whether your product lot number is impacted
Click here to view a full list of products impacted in your country
Bausch + Lomb is conducting a voluntary recall of certain lots of Biotrue® contact lens solution, ReNu® MPS Multi-purpose solution sensitive eyes, ReNu® MultiPlus contact lens solution, Boston® cleaner, Boston® conditioning solution, Boston® Simplus Multi-Action contact lens solution, Sensitive Eyes® contact lens solution, EasySept® contact lens solution, Ophtaxia® eye wash solution, Sensitive Eyes® eye lubricant solution and associated private label brands that were manufactured at its facility in Milan, Italy. These lots are being recalled from consumers, pharmacies, eye care professionals, retailers, distributors and wholesalers.
This voluntary recall is being conducted in Europe, Middle East, Africa, Russia/CIS, Hong Kong and China, although the certain lots of Ophtaxia® eye wash solution are only applicable to France and Hong Kong, and Sensitive Eyes® eye lubricant solution to Hungary, Bulgaria and South Africa. Additionally, the only product being recalled in China is Boston® Simplus Multi-action contact lens solution.
This voluntary recall follows a notification received by Bausch + Lomb from one of its third-party suppliers in Milan, Italy, which sterilizes some components (bottles, plugs and caps) of these products prior to manufacturing in our facility in Milan, Italy, of a compliance issue with its sterilization process. Bausch + Lomb is one of many companies impacted by this situation.
The health and safety of everyone who uses our products is our utmost priority. While there is a low risk of infection with these products, Bausch + Lomb has chosen to voluntarily recall these certain lots of products because we cannot confirm the supplier’s conformance to process compliance requirements for some of the components of these products. No serious adverse events have been reported to date in association with this issue.
No other Bausch + Lomb products or lots are affected by this recall.
Retailers, pharmacies, eye care professionals, distributors or wholesalers who have purchased products directly from Bausch + Lomb, please click here for more information. If the products were not purchased directly from Bausch + Lomb, customers are asked to contact their re-seller to return the product and discuss exchange or refund options.
Consumers who may have these affected products in their possession should take the following steps:
- Insert your product lot number below to verify if your product is impacted.
- If the product is impacted, stop using the product.
- Follow the instructions to register your product.
- After following all instructions, discard the impacted product.
How to find my lot number
See below an example of the bottle and carton labels, which contain the lot number and expiration to easily identify the product.
There is also a pdf listing all the products affected here.
In summary, the affected products are:
Biotrue® multi-purpose solution (60mL, 240mL, 300mL)
Biotrue® multi-purpose solution flight pack (60mL, 2 X 60mL)
Biotrue® multi-purpose solution (2 X 300mL, 4 X 300 mL)
ReNu® MPS multi-purpose solution sensitive eyes (60mL, 120mL, 240mL)
ReNu® MPS multi-purpose solution sensitive eyes flight pack (60mL, 2 X 60mL)
ReNu® MPS multi-purpose solution sensitive eyes (3 X 360mL, 4 X 240mL)
ReNu® MultiPlus multi-purpose solution fresh lens comfort (60mL, 240mL, 3 X 360mL, 4 X 240mL)
EasySept® contact lens solution (120mL, 360mL, 3 X 360mL)
Sensitive Eyes® contact lens solution plus Saline (500mL)FSCA Ref: CAC-2021-005
Boston® Multi Action Solution Special Flight Pack SIMPLUS (2 X 60mL)
Boston® SIMPLUS Multiaction Solution (120mL, 4 X 120mL)
Boston®/Boston® ADVANCE Cleaner (30mL & 4 X 30mL)
Boston®/Boston® ADVANCE Conditioning Solution (120mL & 4 X 120mL)
Boston® ADVANCE Cleaner Conditioning Solution Multipack (1 X 120mL + 1 X 30mL)
Boston® ADVANCE Cleaner Conditioning Solution Starter Kit ADVANCE FORMULA (1 X 30 mL + 1 X 10 mL)
Boots Pharmaceuticals Contact Lens Solution (240mL)
Boots Pharmaceuticals All in One Solution (60mL, 240mL, 360mL, 2x360ml)
Boots Pharmaceuticals Advanced Conditioning Solution (120mL)
Specsavers easyvision ultrapurpose MPS (60mL, 3 x 240mL)
Boots Pharmaceuticals Enhanced All in One Solution (360mL)
Boots Pharmaceuticals Advanced Cleaning Solution (30mL)
Boots Pharmaceuticals Advanced Cleaning and Conditioning Solutions (3 x 120ml + 3 x 30mL, 1 x 60ml + 1 x 15mL
For the past few years our group has been working with health professionals in Wales where until now, apart from very exceptional cases, it has not been possible to have Cross Linking (CXL) performed by the National Health Service. However, at last we have some good news to report.
Health Technology Wales has just issued revised guidance for the use of CXL. Their original report on the topic in 2018 stated that there was insufficient evidence(!) for CXL to be used by the NHS in Wales. The revised guidance now states –
“The evidence supports the routine adoption of corneal cross-linking (CXL) for children and adults with progressive keratoconus. Compared to standard care, CXL slows disease progression and may improve visual acuity. It may also reduce or delay the need for corneal transplantation.
Economic modelling suggests that CXL is cost effective on the basis of an assumed sustained clinical benefit for at least 14 years.”
This now needs to translate into CXL being offered in Welsh hospitals (at the moment, only Singleton Hospital in Swansea does) and that is a decision for the Welsh government. Let’s hope that follows swiftly!
You can read the full guidance (which includes a submission from the Keratoconus Group) …Here
Update from Anne Klepacz-
I have now had some feedback from my contact at HTW –
“Thank you so much for your contributions to this appraisal – our appraisal panel were particularly moved by the testimony provided from the patient group and have asked me to pass on their thanks. I think this is such a great example of how important this work of engagement with patients and groups such as yourselves is for health technology assessments.”
So I in turn would like to thank all our members and forum users who have talked and posted about their KC experience and more recently their CXL experience. Without your voices, we couldn’t have contributed to the review (it’s just a shame that we weren’t consulted back in 2018!)
You’ll find our submission right at the end of the report, in Appendix 4.
A clinical trial in 60 keratoconus patients aged 10-16 years old, most of which were based at the NIHR Clinical Research Facility at Moorfields Eye Hospital, found that a treatment for keratoconus, known as corneal cross linking, was effective at stopping its progression in young patients.
Keratoconus is an eye condition where the normally round, dome-shaped, clear front window of the eye (cornea) progressively thins, causing a bulge to develop. This eventually impairs the ability of the eye to focus properly, potentially causing progressively worsening vision.
It is known that corneal cross-linking treatment can halt keratoconus progression and stabilise vision in adults, but until now we didn’t know the effectiveness of this treatment in young patients. This is particularly important as keratoconus is known to progress faster when the onset is in childhood and early teen years. The results of this study show that treating these younger keratoconus patients with corneal crosslinking is effective in arresting the progression of their disease. The clinical trial results represent evidence previously unavailable which strengthens the cases for making cross-linking available throughout the UK, which at present it is not.
A patient, Anne Klepacz who was the lay representative on the study, through her role as trustee of the Keratoconus Group charity said: “It is very exciting to have the results of this study, giving hard evidence of the effectiveness of corneal crosslinking in young people, and providing reassurance and clarity for both parents and young people with keratoconus. We hope the findings will result in crosslinking becoming widely available throughout the UK.”
Frank Larkin, consultant ophthalmologist at Moorfields Eye Hospital, said: “Our findings suggest that corneal crosslinking should be considered as the first line treatment in progressive keratoconus in young patients. It will be interesting to see the longer term impact of this treatment for these patients and if it means the patients won’t need to wear contact lenses or have a corneal transplantation in later life.”
This post was copied from the Moorfields website
To read the technical details of the Keralink trial click – here
At last we have our first post Covid live event in the diary.
It will take place on 14th September at Sandy Park Stadium, Exeter. Doors open at 10am until 4pm and entrance is FREE!
Pre-registration will be required and can be done via the link below or by emailing the organisers at firstname.lastname@example.org or calling one of the team on 0121 803 5484. Click the link below for more details:
We are keen to get to know our members in the South West so please come along and introduce yourself and perhaps talk to others enquiring about Keratoconus.
Many of our members have been following this study. It has been carried out University College London (UCL), Moorfields, Kings College London and other national and international collaborators and is aimed to investigate the key unsolved questions surrounding keratoconus. Indeed quite a few of our members took part in the genetic study and Stephen Tuft of UCL has thanked the KC Group for its support. You may remember Dr Alison Hardcastle gave an excellent presentation of their findings at our 2019 AGM as reported in our Summer newsletter that year.
The good news is that the latest results from this project have now been published and these are summarised in the the Moorfields Press Release –here
For those with a scientific bent, you can read the full 13 page technical paper – here
In December 2020 I underwent cross linking at Birmingham Midland Eye Centre. The procedure was on both of my eyes and I had the operation under general anaesthetic. I am writing this 6 weeks after the operation, so it is all fairly fresh in my memory.
Me and Signing Up To Cross Linking
I was diagnosed with KC as a teenager over 10 years ago. As a teenage boy and then someone entering their early twenties at university, I didn’t want to hear or talk about KC. It’s only in recent years that I have made more of an effort to look after my eyes. I had heard murmurings about cross linking over the years, but it was never something I had considered having done. It was only when I went for my last routine scan of my eyes in November 2020, and was told my condition had deteriorated again since the previous scan, did I decide to sign the forms and join the waiting list for cross linking. I only signed them under one condition however – I must be put to sleep for it. Having heard the consultant talk about the process of cross linking, it sounded like my worst nightmare. No chance could I have that done whilst awake!! I’m pretty sensitive about my eyes at the best of times, so no way was someone scraping a layer off of my eyes with me awake! I was told choosing general anaesthetic would increase my waiting time for the op, and that combined with the Covid situation, I was looking at a lengthy wait.
2 or 3 weeks had passed since being put on the waiting list for cross linking. I wanted to let my work know that I needed time for the operation and I wanted to give them a heads up of when this may be, so I randomly called up BMEC to see if they could give me an estimated date of my op. I was sat there thinking they wouldn’t be able to give me a date, or they’d say Spring/Summer 2021. The response was ‘can you come in December 29th?’ My response was ‘wait, you mean December this year?? In 2 weeks’ time??’ I must have gotten very fortunate and booked myself in somebody else’s cancellation.
The Operation and Recuperating
In these Covid times, I had to self-isolate 2 weeks before the operation. A few days before going to the hospital I had to take a Covid test – that wasn’t a pleasant way to start Christmas Eve! I also had my temperature regularly checked whilst at the hospital. All was safe.
As for the operation itself, I cannot tell you anything about the experience. I have heard various stories from people who have had cross linking under local anaesthetic, and I have not heard any horror stories. It just sounds a little uncomfortable. It’s all good me saying that in hindsight though, I am very happy with my decision of general anaesthetic.
When I came around after the procedure, my eyes were in a fair bit of pain. I had read someone say the pain was like gravel being stuck in your eyes, I can probably agree with that. Hot gravel.
Having had general anaesthetic, you need to eat something and go to the loo before you can be discharged. My Dad then picked me up and took me home .I went into my room, or cave as it was named due to the darkness inside, and more or less stayed there for 5 days. That’s probably how long it took for the pain to go from my eyes. I kept my eyes closed throughout the 5 days and took my eye drops given to me by the hospital four times a day – anti-inflammatories, anti-biotics and steroid drops. It was a bit difficult at the start to put in the drops – my eyes were sticking closed so it felt wrong/uncomfortable to open them for eye drops. It got better as the days went on. I got given an eye mask at the hospital to wear for sleeping (so you don’t rub your eyes in the night). The pain got less and less over the 5 days, until I finally started to open my eyes for extended periods of time, and then the next challenge began – adjusting to light. Having been through an operation and been closed in a dark room for 5 days, it took a while for my eyes to get used to any kind of light in the house. I built it up slowly, day by day, and bit by bit I could watch TV for longer/look at my phone more often/be in a room with lights on.
After two weeks I was only on the steroid drops twice a day, as these were still needed for a further two weeks. I went to the hospital for a post op check and was told my eyes were OK but still recovering. I originally took two weeks off of work as I had been told I could potentially wear my contact lenses again at this point after the operation. But the hospital signed me off for another two weeks so my eyes could further recover. I don’t have glasses I can wear, so me trying to work without lenses would have definitely been a strain to say the least! Thankfully my work were very understanding about the situation.
Now and After
I have been back at work for two weeks now and more or less returned back to normal life. The contact lenses I am wearing are those fitted for me from before the operation. There are good days and bad days with them at the moment. There’s no guarantee the lenses will give you the same level of vision/ comfort as before the op And there is no point going to get any more fitted as your eyes are still stabilising 6-9 months after cross linking. I believe this is the same for glasses wearers. So the next steps for me are to wait for the next post-op appointment in March, and then see the contact lens people in June for a contact lens fitting for my (hopefully by then) stable eyes.
I don’t think I’m currently in a position to comment on the success of the cross linking procedure – I will have to wait a while yet. It’s important to remind myself that it’s a long term benefit, no matter how impatient I’m feeling!
- Have entertainment to hand: download all the audiobooks/podcasts you can find! Between those and the radio, there’s not much else to do when you’re in the early stages of recovery. If you have an Alexa/Google Nest type thing which has voice control, that’s a bonus!
- Know the layout of your surroundings: you probably think you know the way around your room with your eyes closed – well recovery is the perfect time to test that theory! Make sure there aren’t any hazards in the way and that things you may need to access are in easy places.
- Talk to people – make sure you’re still connecting with people! I was sending voice messages to friends/family over the new year. In particular it was helpful to communicate with someone I met at the West Midlands KC Group. She had had cross linking done a few years ago, so getting her insight/tips were very useful.
Read other Member Stories on our on our Blog – Here
We would like to thank Sight and Sound for hosting the following webinar for us specifically tailored towards keratoconus. The webinar looks at four scenarios taking people at different stages of their lives and demonstrates how technology can support them. The webinar is a mix of real time demonstrations and presentations showing the technology in use.
You can also discuss the recommended products with other members of the KC Group on our Forum.
This is an excellent arrangement whereby Small Grants of up to £15,000 are awarded for research. Fight for Sight forms partnerships with charities like ours, each providing 50% of the funding. The advantage for Fight for Sight is that the charity’s involvement helps direct the investment into projects that are likely to be cost effective and beneficial. From our point of view it enables the KC Group to put the donations we collect to good use in the secure knowledge that Fight for sight will handle all the financial and compliance controls. Fight for Sight also ask an independent panel of experts to assess the applications for funding.
The object of our latest partnership is to develop a lab-based laser tool that is compact and portable, and therefore easier to use in both a lab and clinical setting. The tool will detect/monitor subtle biomechanical structural deficits that occur during early-stage corneal disease progression; specifically, localised thinning of the cornea.
Here is the text of the full Press Release:
Researchers at Loughborough University will work together with experts in the ophthalmology field to develop a lab-based laser tool that is more compact and portable, and therefore easier to use in both a lab and clinical setting. The tool will detect/monitor subtle biomechanical structural deficits that occur during early-stage corneal disease progression; specifically, localised thinning of the cornea.
It is anticipated that the outcome of this project will mean that patients can receive treatment to maintain and restore their vision sooner. Ultimately, this will also have considerable impact on addressing the national and global cornea transplant shortage.
Dr Samantha Wilson is leading the project at Loughborough University. She said: “The ability to understand, detect and diagnose corneal diseases, including keratoconus, at an earlier stage would mean that patients can receive treatment sooner. In the long-term, we expect that such devices will be routinely used by surgeons and ophthalmologists to detect, diagnose and treat corneal diseases before they have a significant effect on vision.”
Philip Jaycock is a Consultant Ophthalmic Surgeon and collaborator on this project at Loughborough University. He said: “The development of devices that can measure the strength of the cornea will help earlier diagnosis and allow further investigation of new treatments to maintain vision and potentially improve vision for patients with keratoconus.”
Chief Executive of Fight for Sight, Sherine Krause, said: “We’re delighted to be funding this valuable research project. We know that early detection is hugely important for sight-threatening eye conditions and this in turn will lead to better outcomes for people with keratoconus and other corneal diseases. Eye research is more important than ever in the age of the Covid-19 pandemic and we must continue to fund research for new, more efficient tests, treatments and cures for the leading causes of blindness and sight loss.”
Chairman of The Keratoconus Self-Help and Support Association, David Gable, said: “Late diagnosis is one of our greatest concerns. There is now an effective treatment known as collagen crosslinking that can stop the progression of the disease, thus avoiding the necessity of specialist contact lenses and transplant surgery. We are happy to fund this important research into the early detection of the condition.”