BVI GOVAN MANIPULATOR

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED REGARDING A CASE OF SEVERE POST-OPERATIVE INFLAMMATION, INCLUDING KERATITIS, FOLLOWING THE USE OF BVI PRODUCT REFERENCE (B)(4) - 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 (B)(4) - BVI GOVAN MANIPULATOR, A DEVICE INCLUDED WITHIN THE SURGICAL PACK AND DESIGNED FOR TISSUE MANIPULATION DURING CATARACT SURGERY. AS THE (B)(4) - 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. CODE G HAS BEEN UPDATED FROM 4755 TO 1028 TO BETTER DESCRIBE THE AFFECTED COMPONENT.

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.