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

Lot Number 288463F

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

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/03/2018

Event Type  Injury  

Event Description

I used the alcon clear care contact solution.I followed directions completely and even left my contacts in the case for longer than required, and still ended up with hydrogen peroxide in my eye."is the product over-the-counter: yes, how was it taken or used: solution for contacts, did the problem stop after the person reduced the dose or stopped taking or using the product: no." dates of use: (b)(6) 2018.

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON
• MDR Report Key: 7320568
• MDR Text Key: 101894478
• Report Number: MW5075725
• 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: 03/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2019
• Device Lot Number: 288463F
• 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): Hospitalization
• Patient Age: 26 YR
• Patient Weight: 101