MAUDE Adverse Event Report: ALCON LABORATORIES, INC. OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION (ENHANCED COMFORT); ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 305889F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Pain (1994); Blurred Vision (2137); Excessive Tear Production (2235); Increased Sensitivity (4538); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/06/2020

Event Type  Injury  

Event Description

Discomfort associated with contact lenses use began several months ago: itchiness, pain, tearing, excessive mucus production, blurred vision, light sensitivity.It progressed to the point where it was no longer possible to wear contacts as of (b)(6) 2020, and blurriness and light sensitivity would persist for 1-2 days even after contacts were not worn.Symptoms improved after avoiding contact wear for several days, but returned after 1-2 days of wearing them again.I began to suspect opti-free when i noticed that things were fine for the first day of using a new pair of lenses, and then symptoms resumed after the new pair was stored in opti-free solution overnight.I also began to notice that opti-free drops seemed to exacerbate mucus production.Since stopping all use of these products, symptoms have been gradually resolving, even when contacts are worn and other eye drops are used.The most recently purchased/used lots of these products were: (1) opti-free replenish multi-purpose disinfecting solution (enhanced comfort) (alcon (b)(4), lot 305889f, exp.2021-03-31); (2) opti-free puremoist rewetting drops (alcon lot 100vn, exp.2021-11- 30).Reduced vision.Aleve (naproxen sodium) taken occasionally for pain, including pain associated with use of these products.Fda safety report id # (b)(4).

• Brand Name: OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION (ENHANCED COMFORT)
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 10717933
• MDR Text Key: 212780532
• Report Number: MW5097382
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/20/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Lot Number: 305889F
• 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: 42 YR
• Patient Weight: 77