MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS 12 FL OZ; CONTACT LENS SOLUTION

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

Patient Problems Itching Sensation (1943); Blurred Vision (2137); Halo (2227)

Event Date 03/18/2017

Event Type  No Answer Provided  

Event Description

I recently used clear care plus contact lens solution from alcon.I got itchy eyes and my vision turned very poor while i have my contacts in my eyes.I could see halos around light especially at night.And everything is foggy.I just noticed that so many people have reported this same issue online but the company is still selling this product.Retailer: (b)(6).Purchase date: (b)(6) 2017.This date is an estimate.

• Brand Name: CLEAR CARE PLUS 12 FL OZ
• Type of Device: CONTACT LENS SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 6575526
• MDR Text Key: 75546312
• Report Number: MW5069834
• Device Sequence Number: 1
• Product Code: LPN
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR