MAUDE Adverse Event Report: ALCON CLEAR CARE 3% HYDROGEN PEROXIDE

Lot Number 268633F

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Burning Sensation (2146); Excessive Tear Production (2235)

Event Date 05/21/2017

Event Type  Injury  

Event Description

Alcon clear care contact lens solution severely burned my eyes afer using the product exactly as instructed on the packaging.I have been a contact lens wearer for over 40 years, so i'm well aware of how to care for my lenses and know not to confuse similar-looking solutions.After the lenses soaked for the required minimum 6 hours, i took them out and put both lenses in my eyes.Almost instantly, my eyes started burning and tearing so badly that i was almost unable to get the lenses back out.It was as if the solution had not neutralized at all.The supplied lens case was first used only a week ago, so it's not too old.This is not the first time this has happened; it has happened numerous times in the past few years but there is never any way to predict whether the lenses will burn my eyes or whether they will be fine, with solution fully neutralized.After this incident though, i will no longer use this product.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Did the problem return if the person started taking or using the product again: yes.Why was the person using the product: to deep clean and remove protein deposits from contact lenses.

• Brand Name: CLEAR CARE 3% HYDROGEN PEROXIDE
• Type of Device: CLEAR CARE 3% HYDROGEN PEROXIDE
• Manufacturer (Section D): ALCON
• MDR Report Key: 6585723
• MDR Text Key: 75852249
• Report Number: MW5069967
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Lot Number: 268633F
• 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: 54 YR