InjuryMSR
ADVANCED FLOW SYSTEM PACK
Received Jun 30, 2009 · Event occurred Apr 16, 2009
Report 1920664-2009-00147 · MDR key 1409236
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Endophthalmitis
- Loss of Vision
Narrative
Description of Event or Problem
FOLLOWING CATARACT SURGERY, THE PT DEVELOPED ENDOPHTHALMITIS ONE DAY POST-OP, AND AN EVISCERATION OF THE EYE WAS PERFORMED. THE CAUSE CANNOT BE DETERMINED; HOWEVER, THE CAUSE IS NOT LIKELY DUE TO THE DEVICE.
Additional Manufacturer Narrative
SEE MDR 1920664-2009-00146 FOR THE INTRAOCULAR LENS, AND MDR 1920664-2009-00148 FOR THE VISCOELASTIC USED WITH THIS DISPOSABLE PACK. A REVIEW OF OUR COMPLAINT SYSTEM INDICATED NO OTHER REPORTS FOR THIS LOT HAVE BEEN RECORDED. THE STERILIZATION AND LOT HISTORY RECORDS WERE VIEWED AND FOUND TO BE ACCEPTABLE.