How do I report these defective contact lenses?
December 7, 2016 9:40 AM Subscribe
I want to report faulty contact lenses to someone (I'm in the UK), or to sue the manufacturer. Who do I go to?
I've worn silicone hydrogel contact lenses (CIBA Vision Air Optix for Astigmatism) for years, but recently found myself unable to wear them. One eye gave me lots of trouble – irritation, discomfort, dryness, and the lens not centering properly. I couldn't keep the lenses in for more than a few hours. This persisted for months, even when changing to a new batch of lenses. I was considering giving up on contact lenses altogether.
I went to an optician while wearing the lenses and was told I was having an allergic reaction to something (there were papillae under my eyelid – she described it as "very bumpy"). She advised lubricating eye drops and anti-allergy drops for a couple of weeks, and eventually switching lenses.
Switching solutions didn't help, but switching to a different brand of lenses did. The eye is still a little dry, but I can at least wear lenses again and I'm overjoyed.
Funnily enough, lots of other people report having problems with these lenses (or rather, with the similar Air Optix Aqua lens): http://www.lenscatalogue.co.uk/product-reviews.asp?LensID=309
It sounds like a serious manufacturing defect. The company I buy my lenses from has offered to send them back to the manufacturer for analysis – should I take them up on that or do I give up my only evidence by doing so?
I want a refund, but if a product recall needs to happen, who do I go to to report this? Should I be talking to a solicitor?
I've worn silicone hydrogel contact lenses (CIBA Vision Air Optix for Astigmatism) for years, but recently found myself unable to wear them. One eye gave me lots of trouble – irritation, discomfort, dryness, and the lens not centering properly. I couldn't keep the lenses in for more than a few hours. This persisted for months, even when changing to a new batch of lenses. I was considering giving up on contact lenses altogether.
I went to an optician while wearing the lenses and was told I was having an allergic reaction to something (there were papillae under my eyelid – she described it as "very bumpy"). She advised lubricating eye drops and anti-allergy drops for a couple of weeks, and eventually switching lenses.
Switching solutions didn't help, but switching to a different brand of lenses did. The eye is still a little dry, but I can at least wear lenses again and I'm overjoyed.
Funnily enough, lots of other people report having problems with these lenses (or rather, with the similar Air Optix Aqua lens): http://www.lenscatalogue.co.uk/product-reviews.asp?LensID=309
It sounds like a serious manufacturing defect. The company I buy my lenses from has offered to send them back to the manufacturer for analysis – should I take them up on that or do I give up my only evidence by doing so?
I want a refund, but if a product recall needs to happen, who do I go to to report this? Should I be talking to a solicitor?
It seems unlikely that you would be able to successfully sue a manufacturer solely on the basis of your own allergy to their product. I mean, people have allergic reactions to latex, but rubber glove and condom manufacturers are still in business. I can understand your anger that you went through some discomfort before discovering this, but I would have thought that cooperating with the manufacturer to help them work out what ingredient is causing the reaction might do more good overall.
posted by pipeski at 10:02 AM on December 7, 2016 [3 favorites]
posted by pipeski at 10:02 AM on December 7, 2016 [3 favorites]
Best answer: And on further inspection, contact lenses are a class IIa medical device under the MHRA's authority, so take that route. They've issued recalls for lenses in the past.
posted by holgate at 10:06 AM on December 7, 2016 [2 favorites]
posted by holgate at 10:06 AM on December 7, 2016 [2 favorites]
Best answer: Hi, I do regulatory toxicology work for medical devices. Your first line of approach is to submit this information to the MHRA through the Yellow Card Scheme (note that where you live can slightly change the way you report this).
This incident, as described, is within the range of acceptable safety parameters for most contact lenses. The product you bought has a (legally mandated) product insert or description online that gives details on the proportion of people who developed certain adverse effects during the testing conducted before the lenses were approved for the market. Purchasing and using a device like a contact lens is (generally speaking) consenting to the possibility of expected side effects. That's not always the case, though, and it doesn't change the fact that you can and should report this adverse effect to MHRA.
A big part of how drugs and devices are improved over time is by having an accurate picture of how it works in everyday people out in the world, not in controlled clinical settings. Government regulators and drug/device manufacturers are legally required to carry out this so-called post-market surveillance. Reporting your incident to MHRA and the manufacturer would be ideal.
If you have grounds for follow-up beyond the medical treatment you've already received (along with switching products), MHRA may let you know. Otherwise you'd have to contact an attorney specializing in medical device claims and go through that process. From the limited information you've shared here, you're unlikely to receive compensation sufficient to justify legal action.
posted by late afternoon dreaming hotel at 10:21 AM on December 7, 2016 [9 favorites]
This incident, as described, is within the range of acceptable safety parameters for most contact lenses. The product you bought has a (legally mandated) product insert or description online that gives details on the proportion of people who developed certain adverse effects during the testing conducted before the lenses were approved for the market. Purchasing and using a device like a contact lens is (generally speaking) consenting to the possibility of expected side effects. That's not always the case, though, and it doesn't change the fact that you can and should report this adverse effect to MHRA.
A big part of how drugs and devices are improved over time is by having an accurate picture of how it works in everyday people out in the world, not in controlled clinical settings. Government regulators and drug/device manufacturers are legally required to carry out this so-called post-market surveillance. Reporting your incident to MHRA and the manufacturer would be ideal.
If you have grounds for follow-up beyond the medical treatment you've already received (along with switching products), MHRA may let you know. Otherwise you'd have to contact an attorney specializing in medical device claims and go through that process. From the limited information you've shared here, you're unlikely to receive compensation sufficient to justify legal action.
posted by late afternoon dreaming hotel at 10:21 AM on December 7, 2016 [9 favorites]
Response by poster: Well, that was quick. Sounds like the answer is reporting to the MHRA and returning the lenses to the manufacturer. Thanks all!
posted by henryaj at 10:23 AM on December 7, 2016
posted by henryaj at 10:23 AM on December 7, 2016
It's pretty common to develop an allergy to lenses you wear a lot. There are different kinds of silicone compounds and also coatings. I'm almost out of options after several years of wearing lenses as I keep developing sensitivities to them. It's a bummer but not a defect.
posted by fshgrl at 10:23 AM on December 7, 2016
posted by fshgrl at 10:23 AM on December 7, 2016
Response by poster: > It's pretty common to develop an allergy to lenses you wear a lot
Totally, and that was my assumption at first, but it sounds like a number of people all became unable to wear these lenses at around the same time. Made me wonder if something bigger was afoot, like a manufacturing problem.
Sorry to hear about you becoming sensitised to them, though. LASIK for all!
posted by henryaj at 10:26 AM on December 7, 2016
Totally, and that was my assumption at first, but it sounds like a number of people all became unable to wear these lenses at around the same time. Made me wonder if something bigger was afoot, like a manufacturing problem.
Sorry to hear about you becoming sensitised to them, though. LASIK for all!
posted by henryaj at 10:26 AM on December 7, 2016
It's possible that what you are actually allergic to is the denatured proteins which build up on the lenses. Your body no longer recognizes the protein from your tears as something it has, itself, produced, and an allergic response results in the form of Giant Papillary Conjunctivitis (GPC). The build up occurs differently on different types/brands of lenses, and some lenses are specifically manufactured to resist it, but some people become so sensitive that the only option is daily wear disposables.
posted by ereshkigal45 at 11:01 AM on December 7, 2016
posted by ereshkigal45 at 11:01 AM on December 7, 2016
I went to an optician...
Not an ophthalmologist? Opticians are not doctors, they don't specialize in the medical care of the eye. If you haven't, you should seek a medical opinion from someone trained and licensed to do so.
When it comes to contact lenses and anything in direct contact with my cornea and membranes, I wouldn't seek care from anything less.
posted by JoeZydeco at 12:49 PM on December 7, 2016 [3 favorites]
Not an ophthalmologist? Opticians are not doctors, they don't specialize in the medical care of the eye. If you haven't, you should seek a medical opinion from someone trained and licensed to do so.
When it comes to contact lenses and anything in direct contact with my cornea and membranes, I wouldn't seek care from anything less.
posted by JoeZydeco at 12:49 PM on December 7, 2016 [3 favorites]
Response by poster: As other people seem to be having similar problems (someone on MeFi even messaged me after I posted this thread!) I made a site where they can report them:
http://airoptixallergy.com/
posted by henryaj at 3:42 AM on December 10, 2016
http://airoptixallergy.com/
posted by henryaj at 3:42 AM on December 10, 2016
This thread is closed to new comments.
posted by holgate at 9:55 AM on December 7, 2016 [2 favorites]