MalfunctionHRD
ALLERGAN CUP (GORETEX)
Received Oct 27, 2005 · Event occurred Aug 24, 2005
Report 2020664-2005-00027 · MDR key 757887
Device
Generic name
Contact Lens Care Product
Manufacturer
Allergan, Inc.Model number
NACatalog number
NA
Lot number
NA
Product problems
- Break
- Crack
- Leak/Splash
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
CUPS NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem
THE MANUFACTURER OF A CONTACT LENS CARE CUP FOR USE WITH 3 PERCENT HYDROGEN PEROXIDE SYSTEMS RECEIVED A REPORT FROM ANOTHER COUNTRY THAT THREE LENS CUPS CRACKED DURING NEUTRALIZATION. NO PATIENT INJURY OCCURRED. EACH CUP CRACKED ON THE BOTTOM, SLOWLY OVER A NUMBER OF DAYS, AND SOLUTION EVENTUALLY LEAKED THROUGH THE CRACKS. THE LENS CUPS ARE NOT AVAILABLE FOR EVALUATION BECAUSE THEY WERE DISCARDED BY THE CUSTOMER.