VORTEX SURGICAL

Additional Manufacturer Narrative

AFTER AN INVESTIGATION WE HAVE DETERMINED THAT SOME TIPS HAVE ABNORMALITIES THAT MAY PREVENT INSERTION INTO A 25GA CANNULA OR PROVIDE RESISTANCE REMOVING THE DEVICE FROM THE CANNULA. PRODUCTION AND QUALITY CONTROL HAVE BEEN MADE AWARE OF THE ISSUE TO HELP PREVENT REOCCURRENCE. DEVICES ARE 100% CHECKED ON CANULA COMPATIBILITY PRIOR TO RELEASE. THE ASSEMBLY LOT 040-2509-288 THAT MAY BE AFFECTED CONTAINING 295 ASSEMBLIES. THESE 295 ASSEMBLIES WERE USED IN ONE FINISHED GOOD STERILE LOT (2509040) CONTAINING 59 BOXES. WE HAVE RECALLED ALL 59 BOXES.

Description of Event or Problem

SURGEON HAD DIFFICULTY GETTING VS0135.25 ILLUMINATED FLEX-TIP LASER PROBE TO PASS THROUGH TRANSITION OF THE CANNULA. CANNULA PULLED OUT OF THE EYE. NO PATIENT HARM NOTED BY SURGEON.