MAUDE Adverse Event Report: BAUSCH AND LOMB PEROXICLEAR; ACCESSORIES, SOFT LENS

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problem Burning Sensation (2146)

Event Date 10/01/2016

Event Type  Injury  

Event Description

I was using peroxiclear for contact lenses and noticed that even after leaving my contacts in the solution for 8 to 9 hours, the solution would burn my eyes.Then one day i went to (b)(6) to get more peroxiclear solution and it was no longer available due to the voluntary recall.

• Brand Name: PEROXICLEAR
• Type of Device: ACCESSORIES, SOFT LENS
• Manufacturer (Section D): BAUSCH AND LOMB
• MDR Report Key: 7302390
• MDR Text Key: 101295837
• Report Number: MW5075564
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 93