MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE PLUS CONTACT LENSE CLEANER ; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 314967F

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Burning Sensation (2146); Injury (2348)

Event Date 11/02/2019

Event Type  Injury  

Event Description

I used clear care plus contact lense cleaner with 3%peroxide to rinse my rt contact lense.I have experienced very bad burning and stinging to my eye.I might end up going to the doctor for a remedy as i have flushed the eye with water and saline but it still hurts.I have very bad eye sight without my glasses.I feel that if clear care contact lense cleaner would put their product in a bottle shaped much differently than a regular saline contact lense bottle that my injury as well as many others could be totally avoided and prevented.Did the problem stop after use stopped: yes.How was it used: ophthalmic.Dates of use: (b)(6) 2019 - (b)(6) 2019.

• Brand Name: CLEAR CARE PLUS CONTACT LENSE CLEANER
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 9286421
• MDR Text Key: 165594073
• Report Number: MW5090916
• 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: 11/02/2019

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 Operator: No Information
• Device Expiration Date: 06/30/2021
• Device Lot Number: 314967F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 63