InjuryHNM
VISITEC 5192
Received Nov 21, 1997 · Event occurred Nov 6, 1997
Report 134223 · MDR key 134223
Device
Product problems
- Break
Patient
62 YR
- Failure of Implant
Narrative
Description of Event or Problem
FRONTALIS SUSPENSION OF THE RIGHT EYE WAS PERFORMED WITH SILICONE ROD SUPPLIED PASSING NEEDLES. CARE COMPLETED AND PT TO RECOVERY WITH WELL POSITIONED LID. APPROX HALF HOUR LATER PT NOTED A POPPING IN HER LID AND THE IMMEDIATE DROPPING OF THE LID. SHE WAS TAKEN BACK TO SURGERY AND IT WAS FOUND THAT THE LOOP OF SILICONE HAD BROKEN ON THE MED LIMB OF THE LOOP NEAR THE LID MARGIN. IT APPEARED TO HAVE JUST FRACTURED. THE WATSHY SLEEVE AND LOCKING STITCH WERE IN PLACE THE SLING WAS REPLACED WITH ANOTHER SILICONE ROD, AND SHE HAS HAD NO FURTHER SLIPPAGE OR BREAKAGE. NOW 5 WEEKS OUT.