inforMED
InjuryHNM

VISITEC 5192

Received Nov 21, 1997 · Event occurred Nov 6, 1997

Report 134223 · MDR key 134223

Device

Generic name

Frontalis Suspension Ptosis Set

Manufacturer

Visitec

Model number

5192

Catalog number

*

Lot number

050996

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.