MAUDE Adverse Event Report: ALCON RESEARCH, LTD CLEAR CARE PLUS

Model Number CLEAR CARE PLUS

Device Problem Accessory Incompatible (1004)

Patient Problem Corneal Clouding/Hazing (1878)

Event Date 07/18/2018

Event Type  malfunction  

Event Description

I wear acuvue oasys contact lenses and have for several years.I also use hydrogen peroxide based cleaning and storage solutions and have for several years as well.I have used name and store brands without issue.I recently began using alcon clear care plus solution, which is claimed as compatible with my lenses.Directions were followed.My vision began to develop a haze after 2-3 days use with this solution.Everything, particularly brightly lit objects, like looking through a window, have a haze around them, as if it were a smoky or foggy room.It appears that the solution is damaging my lenses, the only remedy i have found is to replace the lenses completely.After this experience, i looked online, and very quickly found this to be a common problem.(b)(6) or (b)(6) reviews show many people with the same reports, many questioning how this product is not recalled.At best, this is simply incompatible and damaging people's contact lenses, and at worst, it could be affecting people's eyes/vision.I am reporting this directly to fda based on my experience reporting this to alcon.I reported this complaint to them just now, and while professional and courteous, they told me to return the product to the store i bought it from ((b)(6)) for reimbursement, because "they have been taking it back." based on that response, i immediately asked if this is a known problem, and was told that they have received these kinds of complaints before.I have spent my career in the medical device/pharma business, many years in quality, and this sounds very much like what we would call a "stealth recall." i am marking to withhold my identity from the mfr due to working in this industry.

• Brand Name: CLEAR CARE PLUS
• Type of Device: CLEAR CARE PLUS
• Manufacturer (Section D): ALCON RESEARCH, LTD
• MDR Report Key: 7709843
• MDR Text Key: 114878660
• Report Number: MW5078502
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• 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: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2020
• Device Model Number: CLEAR CARE PLUS
• Device Lot Number: 292074F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 113