InjuryHQJ
MIRAGEL
Received Sep 20, 2003 · Event occurred Jun 28, 2000
Report MW1029528 · MDR key 486396
Device
Generic name
Scleral Buckle Implant
Manufacturer
Mira, Inc.Model number
907Catalog number
*
Lot number
H164
Product problems
- Degraded
- Explanted
- Material Fragmentation
- Other (for use when an appropriate device code cannot be identified)
Patient
42 YR
- Visual Impairment
- Surgical procedure
Narrative
Description of Event or Problem
THE MIRAGEL IMPLANT INCURRED SWELLING AND DEGRADATION OVER THE COURSE OF SEVERAL YEARS. IMPLANT WAS REMOVED AND FOUND TO BE SWOLLEN AND FRAGMENTED. PT HAS LOST A SIGNIFICANT AMOUNT OF VISION IN THEIR RIGHT EYE.