MAUDE Adverse Event Report: ALCON RESEARCH, LLC OPTI-FREE PUREMOIST WITH HYDRAGLYDE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 118XF

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

Patient Problems Headache (1880); Epistaxis (4458); Unspecified Respiratory Problem (4464); Eye Pain (4467)

Event Date 05/26/2023

Event Type  Injury  

Event Description

Used opti free pure moist solution and after worsening eye pain and irritation as well as congestion, nosebleeds, and sinus headaches over the last months starting in january.I went to the doctor and couldn't figure it out.We blamed it on seasonal allergies.Then i noticed a nasty moldy smell and looked it up and found a subreddit full of complaints about the same brand and the same expiration date with slightly varied serial numbers.This is not the first time i have used a moldy smelling bottle.I have been using it since january when my other symptoms started but when i noticed the smell i would toss out my contact case and not the solution! alcon has been asking users to send the bottles back to them which is fine but we never get to find out what was wrong with it or what was done.I first encountered a moldy smell back in 2021 and on and off over the last two years and only with this specific brand and type- puremoist source of reddit: (b)(6).

• Brand Name: OPTI-FREE PUREMOIST WITH HYDRAGLYDE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 17039219
• MDR Text Key: 316433316
• Report Number: MW5118017
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 118XF
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: OMEPRAZOLE 10MG DAILY VITAMIN D 50,000 IU WEEKLY.
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White