BVI GOVAN MANIPULATOR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING INVESTIGATION CONCLUSIONS.

Description of Event or Problem

A COMPLAINT WAS RECEIVED CONCERNING A CASE OF SEVERE POST-OPERATIVE INFLAMMATION, INCLUDING KERATITIS, FOLLOWING THE USE OF THE BVI PRODUCT REFERENCE MMK5310/1 - PACK PÔLE VISION, A SET OF OPHTHALMIC DEVICES INTENDED TO AID IN REFRACTIVE SURGERY. THE CUSTOMER SUSPECTED THAT THE PATIENT'S OUTCOME MAY BE ASSOCIATED WITH THE USE OF MMSU1102S - BVI GOVAN MANIPULATOR, A DEVICE INCLUDED IN THE REFERENCED PACK AND INTENDED FOR TISSUE MANIPULATION DURING CATARACT SURGERY.THE PATIENT'S CONDITION REQUIRED HOSPITALISATION, ALTHOUGH IT WAS NOT SPECIFIED WHETHER THIS WAS INITIAL OR PROLONGED. ADDITIONAL FOLLOW-UP QUESTIONS WERE SUBMITTED REGARDING THE PATIENT'S CURRENT STATUS, HEALTH CONSEQUENCES, APPLIED MEDICAL TREATMENTS, AND ANY OBSERVED MALFUNCTION OF THE BVI PRODUCT. HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED REGARDING A CASE OF SEVERE POST-OPERATIVE INFLAMMATION, INCLUDING KERATITIS, FOLLOWING THE USE OF BVI PRODUCT REFERENCE MMK5310/1 - PACK PÔLE VISION (UDI (B)(4)), A SET OF OPHTHALMIC DEVICES INTENDED TO SUPPORT REFRACTIVE SURGERY PROCEDURES. THE CUSTOMER EXPRESSED CONCERN THAT THE PATIENT'S OUTCOME MAY BE ASSOCIATED WITH THE USE OF THE MMSU1102S - BVI GOVAN MANIPULATOR, A DEVICE INCLUDED WITHIN THE SURGICAL PACK AND DESIGNED FOR TISSUE MANIPULATION DURING CATARACT SURGERY. AS THE MMSU1102S - BVI GOVAN MANIPULATOR IS PART OF THE PACK AND NOT DISTRIBUTED SEPARATELY, IT DOES NOT HAVE AN INDIVIDUAL UDI NUMBER. THEREFORE, NO SEPARATE UDI WAS AVAILABLE FOR ENTRY IN THE RELEVANT SECTION OF THIS REPORT. THE BVI QUALITY ASSURANCE DEPARTMENT CONDUCTED A FULL INVESTIGATION IN LINE WITH INTERNAL PROCEDURES. THIS INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND CURRENT PROCESS CONTROLS. ALL MANUFACTURING STEPS WERE FOUND TO BE PROPERLY DOCUMENTED, WITH NO NONCONFORMITIES IDENTIFIED FOR THE AFFECTED PRODUCT. AT BVI BIDFORD FACILITY, AFTER PACKAGING, PRODUCTS ARE SENT DIRECTLY FOR ETO STERILIZATION. PRODUCT STERILISATION IS COMPLETED BY ETHYLENE OXIDE (ETO) STERILISATION IN ACCORDANCE TO A VALIDATED SYSTEM WHICH ASSURES A 10-6 STERILITY ASSURANCE LEVEL. STERILISATION VALIDATION IS ROUTINELY EVALUATED TO CONFIRM STERILITY ASSURANCE. INTERNALLY, ALL COMPONENTS ARE PACKAGED IN A CONTROLLED CLEANROOM ENVIRONMENT, WHERE APPROPRIATE CONTROLS ARE IN PLACE TO MINIMIZE THE RISK OF CONTAMINATION. GOVAN MANIPULATOR PRODUCT NO. MMSU1102, LOT NO. 3521163 WAS MANUFACTURED UNDER SUBCONTRACTOR. HOWEVER THE STERILIZATION PROCESS IS COMPLETED AFTER THE KIT ASSEMBLY, THEREFORE THE RISK OF CONTAMINATION FROM SUPPLIER IS LOW. DUE TO LACK OF SAMPLES, BVI IS UNABLE TO CONFIRM OR REPLICATE THE DEFECT AS REPORTED. WITHOUT THE PHYSICAL SAMPLE AND ADDITIONAL CUSTOMER INPUT, THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE OR VALIDATE THE EXISTENCE OF THE ISSUE. FOLLOWING A THOROUGH INVESTIGATION, IT HAS BEEN DETERMINED THAT NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED AT THIS TIME. THE ISSUE REPORTED DOES NOT INDICATE A SYSTEMIC OR RECURRING PROBLEM, AND NO FURTHER ACTION IS WARRANTED. THE COMPLAINT HAS BEEN FORMALLY ACKNOWLEDGED AND RECORDED IN BVI'S COMPLAINT MANAGEMENT SYSTEM. BVI WILL CONTINUE TO MONITOR CUSTOMER FEEDBACK AND WILL TAKE APPROPRIATE ACTION SHOULD ANY UNFAVORABLE TREND BE OBSERVED.