MalfunctionHRD
ALLERGAN CUP (GORETEX)
Received Oct 27, 2004 · Event occurred Jul 6, 2004
Report 2020664-2004-00025 · MDR key 903967
Device
Generic name
Contact Lens Care Product
Manufacturer
Allergan, Inc.Model number
NACatalog number
NA
Lot number
NA
Product problems
- Break
- Explode
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
CUP UNVAILABLE 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 A LENS CASE EXPLODED. NO PATIENT INJURY WAS REPORTED. THE LENS CUP IS UNAVAILABLE FOR EVALUATION.