MalfunctionHQJ
MIRAGEL SCLERAL BUCKLE
Received Nov 7, 2007 · Event occurred Oct 3, 2007
Report 948929 · MDR key 948929
Device
Product problems
- Explanted
Patient
49 YR
- Pain
- Increased Sensitivity
- Discomfort
- Surgical procedure
- Drainage
Narrative
Description of Event or Problem
A PATIENT WHO HAD CARRIED THE DIAGNOSIS OF TURNER SYNDROME SINCE SHE WAS 10 SUFFERED A RETINAL DETACHMENT 16 YEARS AGO, AND DESPITE SURGICAL ATTEMPTS OF REATTACHMENT SHE DEVELOPED NO LIGHT PERCEPTION DUE TO RECURRENT DETACHMENT AND PROLIFERATIVE VITREAL RETINOPATHY OF THE RIGHT EYE. THE BUCKLE CONSISTED OF A MIRAGEL SPONGE THAT ULTIMATELY CAUSED CONSIDERABLE DISCOMFORT FOR THE GLOBE. THE PATIENT HAD REMOVAL OF THE SCLERAL BUCKLE DUE TO THE PAIN AND DRAINAGE FROM THE "MIRAGEL."