LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE

Additional Manufacturer Narrative

SECTION A2, A4, A5 UNKNOWN/NOT PROVIDED. SECTION D4: LOT#: UNKNOWN/NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. SECTION D4: UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. A PARTIAL NUMBER HAS BEEN PROVIDED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. SECTION H3-OTHER (81): THE LIPIFLOW SYSTEM ACTIVATOR WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

ACCOUNT REPORTED THAT A PATIENT COMPLETED A LIPIFLOW TREATMENT ON WEDNESDAY, (B)(6) 2023. THE PATIENT GOT A BACTERIAL INFECTION IN BOTH EYES. PATIENT WAS ADAMANT THAT THE LIPIFLOW PROCEDURE CAUSED THE INFECTION. DOCTOR WAS ON THE PHONE WITH THEM ON AND OFF ALL DAY(B)(6) 2023 AND SCHEDULED A FOLLOW UP WITH A CORNEAL SPECIALIST FOR (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM INSTEAD AND THE ER DOCTOR TOLD THE PATIENT THE LIPIFLOW CAUSED THE INFECTION. CUSTOMER REFUNDED THE PATIENT, AND THE PATIENT WILL NO LONGER BE GOING TO THAT PRACTICE. NO FURTHER INFORMATION PROVIDED. THIS IS FOR THE RIGHT EYE. A SEPARATE REPORT WAS SUBMITTED FOR THE LEFT EYE.