MAUDE Adverse Event Report: ALCON LABORATORIES CLEAR CARE PLUS WITH HYDRAGLYDE

Lot Number 264956F

Device Problem Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Discomfort (2330)

Event Date 07/01/2016

Event Type  Injury  

Event Description

I am a (b)(6) male who has been wearing contact lenses successfully since around 1976, so that's 40 years of uninterrupted contact lens use.About eight or ten years ago, i began wearing silicone hydrogel lenses made by bausch and lomb, first in a monovision fitting, and then later with b and l purevision multi-focal (balafilcona) lenses after i developed presbyopia.My eye care professional at the time recommended that i switch to using alcon clear care solution for cleaning my lenses, which i did, and i found it to be a great product, providing good cleaning and comfortable wearing.I have used clear care ever since.Recently i had to purchase some more clear care product, and the only product in my local drug store available in the twin-pack was alcon's newer formula of clear care with the new hydraglyde additive.I didn't think much about it at the time, since i had been successfully using clear care for years, and thought this must be just a periodic product improvement from your company.After using the new product for the first time, i immediately noticed a difference.It seemed as through my lenses were suddenly cloudy or hazy, i was unable to focus effectively, and the lenses were very uncomfortable.I replace my lenses every 30 days without fail, and always follow proper procedures with regard to hand washing and the use of the cleaning solution.At first i was completely unable to explain this phenomena.I thought at first that perhaps i had inadvertently contaminated my lenses somehow, despite how careful i am with lens hygiene.After the problem did not resolve after a couple of days, i replaced my lenses with a fresh pair, even though they were not due for a replacement.I thought perhaps that i had obtained a bad batch of the clear care solution, so discontinued its use and switched to a small bottle of the original formula (without hydraglyde) that i had been given by my eye care professional.So now i was wearing a fresh pair of lenses and cleaning them with the original clear care solution.My vision returned to normal immediately.After exhausting the small bottle of clear care, on (b)(6) 2016, i opened a brand new bottle of clear care with hydraglyde and cleaned my lenses overnight in a brand new lens case supplied with the product.The next morning after inserting my lenses, i immediately noticed a difference, the lenses were not comfortable, and within minutes i could perceive the same clouding and haziness in my vision that i had experienced before.This did not diminish over the course of the day, in fact it only got worse.The following morning i began to search the web for reports of others who may have been experiencing the same things i was.I found nothing on alcon's website that addressed the situation, in fact all the reviews of this product on their website are glowing with praise.However, after looking further, i found numerous reviews of clear care with hydraglyde on amazon's website that confirmed my suspicions.Of 103 reviews of this product on (b)(6) website, fully 86 percent of them are one-star, the lowest possible rating.Even more telling is that the vast majority of those one-star reviews express the exact same symptoms that i was experiencing.Clearly there is something seriously wrong with this product's formulation that so many people could be expressing the same symptoms after using it simply cannot be a coincidence.On the other hand the original formulation of clear care without hydraglyde has a 77 percent five-star rating, with only an 8 percent one-star rating.Dates of use: (b)(6) 2016.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: yes.

• Brand Name: CLEAR CARE PLUS WITH HYDRAGLYDE
• Type of Device: CLEAR CARE PLUS WITH HYDRAGLYDE
• Manufacturer (Section D): ALCON LABORATORIES
• MDR Report Key: 5849563
• MDR Text Key: 51404917
• Report Number: MW5063847
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 264956F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 68