MAUDE Adverse Event Report: ALCON LABORATORIES LTD. CLEAR CARE PLUS WITH HYDRAGLYDE 16FT OZ STERILE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 292924-F

Device Problem Insufficient Information (3190)

Patient Problem Blurred Vision (2137)

Event Date 09/18/2018

Event Type  Injury  

Event Description

After 20+ years of using alcon's previous clear care contact lens sterilizing product (purchased from (b)(6)) with no problem, i recently started using alcon clear care plus with hydraglyde (purchased from (b)(6); it is the only clear care sterilizing product they sell now).I sterilized my lenses in the usual way following the instructions on the bottle.However, when i removed the contacts from the sterilizer next day and put the lenses in my eyes, my vision became foggy after only an hour's wear.I threw one pair of lenses away thinking the problem was with the lenses since it was the 3rd week for 4-wk-wear lenses.However, i had the same result the next day wearing brand new lenses.After two days i made the connection to the new formula clear care with hydraglyde, i took the lenses out last night at 8 pm (i had put them in at 6 pm); my vision with glasses is still foggy today.After i woke up with still-foggy vision, i looked at the (b)(6) and (b)(6) web sites and there are hundreds other people who had or have the same problem with alcon products containing hydraglyde.I hope my eyes aren't permanently damaged.Why is this product still being sold? the product did not stop after the person reduced the dose or stopped taking or using the product.The product returned if the person started taking or using the product again.Reason for use: the person was using the product to sterilize contact lenses.

• Brand Name: CLEAR CARE PLUS WITH HYDRAGLYDE 16FT OZ STERILE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES LTD. ; ft worth TX
• MDR Report Key: 7897657
• MDR Text Key: 121561892
• Report Number: MW5080033
• 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: 09/19/2018

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 Expiration Date: 12/31/2019
• Device Lot Number: 292924-F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 50