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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Burn (2523); Eye Pain (4467); Unspecified Eye / Vision Problem (4471); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 05/03/2022

Event Type  Injury  

Event Description

This was my second time using the product.The date of my event happened (b)(6) 2022.My contacts soaked in the clear car plus solution and case for about 16 hours.I followed the instructions that were on the packaging and the solution bottle.After i sterilized my hands, i went to put my left contact into my left eye, the contact seated around my cornea, and i experienced an extreme burning sensation.My eye began to spasm from the burn and i had to hold my eye open and scratch at my eye to get the contact out.This lasted for about 45 seconds and i experienced temporary vision loss in my left eye during this incident and immediately after.I flushed my eye with water, however 10 hours later my eye is still slightly burning and very sore.I will be seeking medical attention because of my symptoms.

• Brand Name: CLEAR CARE PLUS
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 14288548
• MDR Text Key: 290952912
• Report Number: MW5109539
• 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: 05/03/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White