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

Lot Number 281558F

Device Problem Material Integrity Problem (2978)

Patient Problems Irritation (1941); Itching Sensation (1943); Blurred Vision (2137)

Event Date 07/24/2017

Event Type  Injury  

Event Description

Purchased clear care plus hydraglyde contact lense solution (new formula by alcon).When i started using it, i had itchy, irritated eyes and blurred vision.When i got suspicious that the problem might be in the new solution, i purchased a bottle of old formula solution (clear care triple action).All issues disappeared.After that did some research online and found out that many people have the same issues with the new formula.It should not be on the market.

• Brand Name: CLEAR CARE HYDRAGLYDE CONTACT LENS SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON
• MDR Report Key: 6809669
• MDR Text Key: 83463601
• Report Number: MW5071723
• 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: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Lot Number: 281558F
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 77