MAUDE Adverse Event Report: ALCON RESEARCH, LLC. OPTI-FREE PURE MOIST; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 10NM3

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Contact Dermatitis (4546)

Event Date 10/20/2021

Event Type  Injury  

Event Description

After alcon replaced opti-free replenish with pure moist contact lens solution, i began experiencing severe dermatitis around both eyes that took months to diagnose and is only now beginning to resolve, but i can no longer use any contact lens solution.

• Brand Name: OPTI-FREE PURE MOIST
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 14266922
• MDR Text Key: 290658435
• Report Number: MW5109470
• 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: 04/29/2022

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 Expiration Date: 05/31/2024
• Device Lot Number: 10NM3
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2022
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White