CYSTOTOME IRRIGATING 27G 5/8IN (10/SP)

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING A SURGICAL PROCEDURE, A CYSTOTOME NEEDLE TIP SWIVELLED WHILE INSIDE THE ANTERIOR CHAMBER OF THE EYE. THE ISSUE WAS IDENTIFIED DURING WITHDRAWAL OF THE DEVICE AFTER COMPLETION OF A J-STYLE RADIAL INCISION. UPON INSPECTION, THE CYSTOTOME WAS SECURELY ATTACHED TO THE SYRINGE; HOWEVER, THE NEEDLE TIP EXHIBITED UNINTENDED MOVEMENT (SWIVELLING) WITH LIGHT PRESSURE, INDICATING A POTENTIAL DEVICE DEFECT. AS A RESULT OF THE MALFUNCTION, THE SHARP TIP PUNCTURED THE CAPSULE OUTSIDE THE INTENDED CAPSULORHEXIS AREA, CAUSING AN ANTERIOR CHAMBER (AC) TEAR. THE PHYSICIAN CONFIRMED THAT THIS WAS NOT CONSIDERED AN EXPECTED COMPLICATION IN THIS CONTEXT. DUE TO THE AC TEAR, THE PROCEDURE WAS PROLONGED AND REQUIRED MULTIPLE UNPLANNED INTRAOPERATIVE INTERVENTIONS. THESE INCLUDED FLUSHING THE ANTERIOR CHAMBER, USE OF VISION BLUE TO HIGHLIGHT THE DAMAGE, REFILLING THE CHAMBER, CAREFUL CONTINUATION OF THE PROCEDURE, AND INSERTION OF IRIS HOOKS TO VISUALIZE AND MANAGE THE EXTENT OF THE TEAR. THE EVENT ALSO RESULTED IN INCREASED INTRAOCULAR INFLAMMATION AND EXTENDED SURGICAL TIME. THE PATIENT WAS IMPACTED BY THE EVENT; HOWEVER, NO PERMANENT IMPAIRMENT OR LONG-TERM OUTCOME HAS BEEN CONFIRMED AT THIS TIME. THE PATIENT IS EXPECTED TO RETURN FOR FOLLOW-UP IN 2-3 WEEKS. INFORMATION REGARDING ADDITIONAL SURGICAL INTERVENTION BEYOND THE INDEX PROCEDURE OR LASTING COMPLICATIONS HAS NOT BEEN FULLY ESTABLISHED. BASED ON THE AVAILABLE INFORMATION, THE SWIVELING OF THE NEEDLE TIP INDICATES A DEVICE MALFUNCTION, AS THE PRODUCT DID NOT MAINTAIN STRUCTURAL INTEGRITY AND DID NOT PERFORM AS INTENDED DURING NORMAL USE. ALTHOUGH PERMANENT HARM HAS NOT BEEN CONFIRMED, THE MALFUNCTION RESULTED IN A SERIOUS INTRAOPERATIVE COMPLICATION REQUIRING SIGNIFICANT CORRECTIVE ACTION. THEREFORE, THIS CASE MEETS THE CRITERIA FOR MEDICAL DEVICE REPORTING, INCLUDING SUBMISSION AS A REPORTABLE EVENT AND FOR U.S. REPORTING UNDER FOREIGN REPORTING REQUIREMENTS, AS THE PRODUCT IS MARKETED IN THE UNITED STATES.