LIPIFLOW ACTIVATOR II

Additional Manufacturer Narrative

DATE OF EVENT UNKNOWN. PATIENT REPORTED THAT STYE FORMED POST TREATMENT AND THE BEST ESTIMATE IS AFTER (B)(6) 2015. LOT#: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. A COMPLETE UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. (B)(4). A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

Description of Event or Problem

PATIENT REPORTED THAT HAD LIPIFLOW PROCEDURE DONE IN (B)(6) 2015 AT (B)(6) INSTITUTE IN (B)(6) . DURING THE PROCEDURE PATIENT REPORTED THAT TECHNICIAN HAD A HARD TIME GETTING THE APPLICATOR UNDER THE LID. PATIENT STATED THAT BECAUSE OF THAT THE TECHNICIAN KEPT PUTTING THE APPLICATOR IT IN & OUT OF THE RIGHT EYE. PATIENT INITIALLY REPORTED THAT AFTER A FEW WEEKS POST TREATMENT A STYE LIKE BUMP DEVELOPED THAT REQUIRED THE EYE DOCTOR CUT IT OPEN HOWEVER, DURING FOLLOW UP THE PATIENT STATED THIS INCIDENT OCCURRED AROUND (B)(6) OR (B)(6) OF 2016 WHICH IS MORE THAT FEW WEEKS POST TREATMENT. PATIENT ALSO REPORTED THAT AROUND (B)(6)/(B)(6) 2016 A STYE FORMED IN THE SAME EYE (RIGHT) SAME LOCATION AND ALSO HAD TO BE CUT OPEN.

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(B)(4) AND CAPA(B)(4).