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

Health Effect - Clinical Codes	Irritation (1941); Burning Sensation (2146); Excessive Tear Production (2235)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer called to report that after using clear care 3% hydrogen peroxide clean and disinfectant solution (ophthalmic solution), she experienced severe eye burning and watery eyes.Consumer believes that the disc that is supposed to be at the bottom of the solution bottle, does not last for the duration of the product, so the solution no longer is being neutralized.Consumer has contacted the manufacturer via email, and has yet to receive a response.She has authorized fda to provide her name in order to facilitate the complaint follow-up.Eye irritation.

• Brand Name: CLEAR CARE
• Common Device Name: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH LLC ; 6201 south fwy, aspex facility ; fort worth TX 76134 2099
• MDR Report Key: 10658443
• Report Number: MW5097177
• Device Sequence Number: 19606519
• Product Code: LPN
• UDI-Device Identifier: 00047113609027
• UDI-Public: 047113609027
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2020
• Patient Sequence Number: 1