VARILUX PHYSIO AR CRIZAL ADVANCED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-05 for VARILUX PHYSIO AR CRIZAL ADVANCED manufactured by Essilor Usa, Inc.

Event Text Entries

[3226950] Both prescription lenses catastrophically failed and i was unable to see well enough to drive a vehicle. I left my regular prescription eye wear in my vehicle and used my prescription sunglasses during the daytime. At night, when i returned to my vehicle, i switched to my regular prescription eye wear but could not see properly to drive. I was about 40 miles from my motel and had to use sunglasses to return to the motel. I do not believe that essilor usa, inc. Adequately alerts users of their prescription lenses of the low temps at which their lenses can fail catastrophically. Essilor usa, inc. Has failed to provide me with the heat distortion temp that can cause catastrophic failure as requested. They only state that their lenses should not be kept in a vehicle. Based on my experience, the heat required for catastrophic failure is unreasonable low and the product should not be allowed to be marketed. Dates of use: (b)(6) 2010 - (b)(6) 2012. Diagnosis or reason for use: lenses to correct eye sight. I have worn prescription lenses for approximately 60 yrs and never had heat damage to lenses when i kept eye wear in as vehicle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5028818
• MDR Report Key: 2943722
• Date Received: 2013-02-05
• Date of Report: 2012-10-22
• Date of Event: 2012-07-18
• Date Added to Maude: 2013-02-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VARILUX PHYSIO
• Generic Name: PROGRESSIVE PRESCRIPTION LENSES
• Product Code: HQG
• Date Received: 2013-02-05
• Model Number: AR CRIZAL ADVANCED
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ESSILOR USA, INC
• Manufacturer Address: 13555 N STEMMONSFREEWAY DALLAS TX 75234 US 75234

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-02-05