ALCON TOTAL PLUS 23 GA VITRECTOMY PAK
Received Aug 20, 2009 · Event occurred Jul 29, 2009
Report MW5012491 · MDR key 1445404
Device
Generic name
Vitrectomy Pak
Manufacturer
Alcon Laboratories, Inc.Catalog number
8065750828
Lot number
BOX NOT SAVED
Product problems
- Material Separation
- Sticking
Patient
45 YR
- Retinal Tear
Narrative
Description of Event or Problem
DURING A PARS PLANA VITRECTOMY FOR REPAIR OF A RHEGMATOGENOUS RETINAL ATTACHMENT, IT WAS NOTED THAT THE VITRECTOMY PROBE BECAME FUSED TO THE TROCAR THROUGH WHICH IT IS PLACED INTO THE EYE. ATTEMPTED REMOVAL OF THE PROBE FORM THE TROCAR RESULTED IN THE OUTER PLASTIC PORTION OF THE TROCAR SEPARATING FROM THE INNER METAL PORTION THROUGH WHICH THE PROBE IS PLACED. THE VITRECTOR WAS ACTIVATED TO CLEAR THE PORT AND THEN THE PROBE/TROCAR COMPLEX WAS REMOVED FROM THE EYE. INSPECTION OF THE RETINA NOTED A GIANT RETINAL TEAR, PRESUMABLY DUE TO VITREOUS INCARCERATION BETWEEN THE PROBE AND TROCAR. DR CONSIDERS THIS EVENT TO BE SERIOUS AND TO HAVE POTENTIAL TO HARM PTS. THE TEAR WAS REPAIRED TO AVOID PERMANENT HARM WITH RECOVERY TO BE ASSESSED AT 12 WEEKS.