MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS HYDRAGLYDE

Lot Number 281559F

Device Problem Material Integrity Problem (2978)

Patient Problems Hypersensitivity/Allergic reaction (1907); Blurred Vision (2137); Burning Sensation (2146); Halo (2227)

Event Date 05/15/2017

Event Type  malfunction  

Event Description

My complaint is regarding clear care hydraglyde contact lens solution.I am a long time user of the regular clear care solution (non-hydraglyde) and have used it for many years without issue.I noticed that clear care released a new version with hydraglyde that was supposed to provide more moisture to your eyes so i decided to try it.For two weeks after.I experienced burning in my eyes, extreme light sensitivity, blurry vision, and halos.I actually had to stop wearing my contacts and after a few days my eyes would get better, but when i would go back to wearing my contacts, the issues would return.I even threw out my lenses and tried a new pair but still was having the same issues.I couldn't figure out what had changed or what was wrong with my eyes.One day it finally occurred to me that i had switched from the original clear care to the clear care with hydraglyde and maybe that was the issue.So of course, i googled clear care hydraglyde to see if there were any others with the same issues.Sure enough, if you go to amazon's reviews of hydraglyde, you will see 200+ complaints of the exact same issues i was having.I was relieved because i realized it likely was the lens solution causing the problem and not a health issue with my eyes.I immediately went back to using the original clear care solution.My symptoms got a little better but i still had blurry vision.I threw out those contacts, wore my glasses for a few days, and then started fresh with a new pair of contact lenses and using only the original clear care solutions.I haven't had a single issue since - my eyes have been perfect.I really think the fda should look into the safety of this product."is the product over-the-counter: yes, how was it taken or used: applied to contact lenses, did the problem stop after the person reduced the dose or stopped taking or using the product: yes." dates of use: (b)(6) 2017.Reason for use: to clean contact lenses.

• Brand Name: CLEAR CARE PLUS HYDRAGLYDE
• Type of Device: CLEAR CARE PLUS HYDRAGLYDE
• Manufacturer (Section D): ALCON
• MDR Report Key: 6746433
• MDR Text Key: 81498769
• Report Number: MW5071251
• 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: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2018
• Device Lot Number: 281559F
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 61