Description of Event or Problem · 0
A CUSTOMER REPORTED THAT IRRIGATING CYSTOTOME NEEDLES SUPPLIED BOTH WITHIN THE BVI CUSTOMEYES KIT KAISER READY BAG (58001238, LOT 6094433) AND AS INDIVIDUALLY PACKAGED IRRIGATING CYSTOTOME NEEDLES PART NUMBER 581610 - IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP) (LOTS 6077513, 6087799, 6087191, 6093750, 6097128, AND 6100520) WERE ALLEGEDLY BENT, MAKING ENGAGEMENT OF THE CAPSULE DURING CATARACT SURGERY DIFFICULT WITHOUT "UNUSUAL MANIPULATION." THE CUSTOMER FURTHER REPORTED THAT THIS MANIPULATION OCCASIONALLY RESULTED IN CAPSULORHEXIS TEARS. THE CUSTOMER INDICATED THAT THE ISSUE MAY HAVE OCCURRED IN APPROXIMATELY 400-600 CASES SINCE (B)(6) 2025. REPORTED CONSEQUENCES INCLUDED PROLONGED SURGICAL TIME AND DELAYED WOUND HEALING IN SOME CASES. HOWEVER, DESPITE FOLLOW-UP REQUESTS, DETAILED PATIENT OUTCOMES, THE NUMBER OF CONFIRMED CAPSULORHEXIS TEARS, THE EXTENT OF PATIENT IMPACT, AND WHETHER ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED COULD NOT BE CONFIRMED. IT WAS DETERMINED THAT ONE REPORT WILL BE SUBMITTED FOR EACH INDIVIDUAL AFFECTED LOT NUMBER OF PART 581610 - IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP). IF THE CUSTOMER LATER CONFIRMS THE NUMBER OF AFFECTED PATIENTS, THE REPORTS WILL BE UPDATED AND ADDITIONAL REPORTS SUBMITTED, IF REQUIRED. ACCORDING TO THE INTENDED USE AND CLINICAL FUNCTION OF THE IRRIGATING CYSTOTOME NEEDLE, PROPER NEEDLE GEOMETRY IS ESSENTIAL FOR CONTROLLED CAPSULORHEXIS CREATION DURING CATARACT SURGERY. A BENT NEEDLE MAY IMPAIR DEVICE PERFORMANCE AND COULD CONTRIBUTE TO INTRAOPERATIVE COMPLICATIONS, INCLUDING UNINTENDED TEARING OF THE CAPSULORHEXIS. SUCH COMPLICATIONS HAVE THE POTENTIAL TO RESULT IN SERIOUS OCULAR INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION, INCLUDING PROLONGED SURGICAL MANIPULATION, VITREOUS LOSS, RETINAL COMPLICATIONS, OR PERMANENT IMPAIRMENT OF VISUAL FUNCTION. ALTHOUGH NO CONFIRMED SERIOUS INJURY HAS BEEN DOCUMENTED IN THE INFORMATION CURRENTLY AVAILABLE, THE POTENTIAL FOR A SERIOUS OUTCOME IF THE ISSUE WERE TO RECUR CANNOT BE EXCLUDED. BASED ON THE AVAILABLE INFORMATION, THIS COMPLAINT MEETS THE CRITERIA FOR REPORTABILITY AS A MALFUNCTION IN THE COUNTRY OF OCCURRENCE, AS IT INVOLVES AN ALLEGED DEVICE MALFUNCTION THAT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. DUE TO THE LIMITED CLINICAL INFORMATION PROVIDED AND THE ABSENCE OF CONFIRMED SERIOUS PATIENT HARM, THE EVENT IS NOT CURRENTLY CLASSIFIED AS A CONFIRMED SERIOUS INJURY REPORT. HOWEVER, THE COMPLAINT REMAINS REPORTABLE BASED ON THE POTENTIAL SEVERITY OF HARM ASSOCIATED WITH THE REPORTED MALFUNCTION UNDER FORESEEABLE CONDITIONS OF USE.