MalfunctionHNM
BD VISITEC
Received Apr 12, 2010 · Event occurred Nov 11, 2009
Report 1664140 · MDR key 1664140
Device
Product problems
- Collapse
Patient
1 MO
- No Code Available
Narrative
Description of Event or Problem
THE BILATERAL SILICONE FRONTALIS SLINGS WERE PLACED IN EYES DUE TO SEVERE PTOSIS WITH A MINIMAL, 2 MM INTERPALPEBRAL FISSURE OPENING, WITH A MAXIMAL BROW ELEVATION. APPROXIMATELY 30 MINUTES AFTER SURGERY, THE LEFT EYE LID WAS SEEN TO DROP INTO COMPLETE PTOSIS WHILE THE PATIENT WAS CRYING. THE DECISION WAS MADE TO BRING THE PATIENT BACK INTO THE OPERATING ROOM TO REVISE THE FRONTALIS SLING OF THE LEFT EYE. THIS WAS ALSO DONE TO DETERMINE THE CAUSE OF THE FAILURE OF THE FRONTALIS SUSPENSION SURGERY ON THE LEFT UPPER EYELID.