MAUDE Adverse Event Report: ALCON CLEAR CARE

Device Problem Use of Device Problem (1670)

Patient Problems Unspecified Infection (1930); Burning Sensation (2146); Discomfort (2330); Eye Burn (2523); Caustic/Chemical Burns (2549)

Event Date 10/25/2017

Event Type  Injury  

Event Description

I used clear care contact solution.I followed the directions on the label, put my contacts in the provided case in the evening, and about 9 hours later took them out and put my contacts in.I experienced a burning sensation, but thought maybe my eyes were just tired.The discomfort continued for a few days, when i eventually went to the eye doctor and he said it looked like i had a chemical burn on my corneas, and they had become infected, probably because i continued to wear my contacts.Since the contact solution contains hydrogen peroxide, they must sit for at least 6 hours, i left mine sit 9.

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• Manufacturer (Section D): ALCON
• MDR Report Key: 6998860
• MDR Text Key: 91110256
• Report Number: MW5073119
• Device Sequence Number: 0
• 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: Other
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 75