MalfunctionHRD
ALLERGAN CUP (GORETEX)
Received Oct 27, 2005 · Event occurred Sep 9, 2005
Report 2020664-2005-00028 · MDR key 757915
Device
Generic name
Contact Lens Care Product
Manufacturer
Allergan, Inc.Model number
NACatalog number
NA
Lot number
NA
Product problems
- Break
- Crack
- Use of Device Problem
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
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 A LENS CUP CRACKED DURING NEUTRALIZATION. NO PATENT INJURY OCCURRED. THE LENS CUP WAS USED WITH AN INCOMPATIBLE PRODUCT - IT WAS NOT USED ACCORDING TO LABELING. THE LENS CUP WAS FORWARDED TO THE MANUFACTURER FOR EVALUATION; RESULTS OF PERFORMANCE TESTING WERE WITHIN SPECIFICATION. EVENT WAS CAUSED BY USER ERROR.