MAUDE Adverse Event Report: BAUSCH & LOMB PEROXI CARE; CLEANING & DISINFECTING SOLUTION

Model Number PEROXI CARE 12OZ SINGLE

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); No Code Available (3191)

Event Date 08/01/2015

Event Type  malfunction  

Event Description

Bausch & lomb peroxi clear.First time to use this product.The platinum catalyst coating in the bottom of the disinfecting/neutralizing container which is part of the product flakes off and contaminates the contact lens while cleaning.The flakes are visible on close examination as small black/dark objects in the neutralized fluid.These particles enter the eye upon inserting the cleaned contact lens, potentially causing pain and harm.White plastic is visible in the platinum catalyst coating where the product has flaked off contaminating the solution and the lens.The disinfecting/neutralizing container is an integral part of the product and should be replaced to avoid further harm.I am preparing to return the material to bausch & lomb.

• Brand Name: PEROXI CARE
• Type of Device: CLEANING & DISINFECTING SOLUTION
• Manufacturer (Section D): BAUSCH & LOMB
• MDR Report Key: 5018374
• MDR Text Key: 23754490
• Report Number: MW5055553
• 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
• Report Date: 08/17/2015

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: Lay User/Patient
• Device Model Number: PEROXI CARE 12OZ SINGLE
• Device Lot Number: GH14054
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1