LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE)
Received Aug 2, 2023 · Event occurred Jun 28, 2023
Report 3012236936-2023-01995 · MDR key 17447603
Device
Generic name
Eyelid Thermal Pulsation System
Manufacturer
Tearscience, Inc.Model number
LFD-2100Catalog number
0803-5001
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Eye Infections
- Eye Infections
Narrative
Description of Event or Problem
ACCOUNT REPORTED THAT A PATIENT COMPLETED A LIPIFLOW TREATMENT ON WEDNESDAY, ON (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 ON (B)(6) 2023 AND SCHEDULED A FOLLOW UP WITH A CORNEAL SPECIALIST FOR ON (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.
Additional Manufacturer Narrative
SECTION D4: UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. A PARTIAL NUMBER HAS BEEN 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.