MAUDE Adverse Event Report: OPTIFREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION; PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 05/01/2016

Event Type  Injury  

Event Description

This is the 2nd occurrence, this happened twice.The first time i wasn't aware it was the solution so i bought new contacts.Then it happened again with the brand new contacts, so i know it is the solution.I used optifree puremoist contact solution and it gave me an eye infection twice.I was not able to open my eyes after using the product to clean my contact lenses, and had to stay home to keep my eyes closed for two days due to pain twice.

• Brand Name: PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION
• Type of Device: PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION
• Manufacturer (Section D): OPTIFREE
• MDR Report Key: 5636703
• MDR Text Key: 44672378
• Report Number: MW5062121
• 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
• Type of Report: Initial
• Report Date: 05/03/2016

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 64