MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE 3% HYDROGEN PEROXIDE; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/19/2021

Event Type  Injury  

Event Description

Used clear care contact solution exactly as indicated, yet had serious side effect necessitating urgent care.Have not been able to open my eye fully in over 24 hours.Is therapy still on-going? yes.

• Brand Name: CLEAR CARE 3% HYDROGEN PEROXIDE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 12518426
• MDR Text Key: 273170129
• Report Number: MW5104147
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: IUD
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR