LIPIFLOW ACTIVATOR II

Additional Manufacturer Narrative

THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

Additional Manufacturer Narrative

DEVICE EVALUATION: THE LIPIFLOW ACTIVATOR, LOT NO. 1821220005 WAS RETURNED TO EVALUATION. A VISUAL EVALUATION WAS PERFORMED. ACTIVATOR LOT# 1821220005 WAS RETURNED OUTSIDE ITS PRIMARY SEAL PACKAGE. THE PRIMARY PACKAGE WAS RECEIVED OPENED, BUT SEAL MARKINGS WERE VISIBLE ON THE TYVEK POUCH. NO DAMAGE ON THE DEVICE WAS OBSERVED, HOWEVER DEBRIS AND FIBER WERE OBSERVED ON THE ACTIVATOR. UNABLE TO DETERMINE THE EXACT CAUSE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

A SURGERY CENTER REPORTED OBSERVED A LIPIFLOW ACTIVATOR NOT SEALED UPON OPENING THE OUTER BOX. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT 1 OF 10 LIPIFLOW ACTIVATORS THAT WERE INDIVIDUALLY PACKAGED WAS NOT SEALED AND WAS AT THE BOTTOM OF THE BOX. THE REMAINING 9 ACTIVATORS WERE SEALED. THE UNSEALED PACKAGE WAS DISCOVERED PRIOR TO USE AND DURING HANDLING. NO PATIENT CONTACT OR PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING THE ACTIVATOR LOT# 1821220005. ALL DEVICES MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.