MAUDE Adverse Event Report: ALCON LABORATORIES, INC OPTI-FREE PURE MOIST; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 1194V 2025-06-30

Device Problems Device Emits Odor (1425); Product Quality Problem (1506)

Patient Problems Red Eye(s) (2038); Fluid Discharge (2686); Eye Infections (4466)

Event Date 03/13/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 i got an eye infection which had a lot of discharge and pinkness in both eyes.The discharge lasted about 10 days.The infection spread to my wife and 3 small children.When i was done with the infection and wanted to resume wearing my contact lenses, i opened a new set of lenses, used a new alcon case, and filled it with my puremoist solution.Being hypersensitive i noticed a strong smell from the contact lens case, i thought it could have been something else in my bathroom, but i realize i had been smelling this for a while.Using it a few more days i confirmed it was definitely the puremoist.I had bought a 2 pack and used an entire bottle and this 2nd bottle is about 1/3 used.

• Brand Name: OPTI-FREE PURE MOIST
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC
• MDR Report Key: 16743272
• MDR Text Key: 313406176
• Report Number: MW5116627
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 1194V 2025-06-30
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 79 KG