LIPIFLOW SYSTEM CONSOLE LFTP-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859623006414), received between Dec 28, 2018 and Apr 13, 2020 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED JOHNSON AND JOHNSON SURGICAL VISION AFTER READING ONLINE THE CONTRAINDICATIONS FOR THE USE OF LIPIFLOW SYSTEM (B)(6). PATIENT REPORTED THAT HER DOCTOR DID NOT FULLY DISCLOSE TO HER THE POSSIBLE CONTRAINDICATIONS OF THE USE OF THE LIPIFLOW PRIOR TO HER TREATMENT ON (B)(6) 2019. PATIENT REPORTED THAT IF SHE KNEW THE POSSIBLE EFFECTS OF THE TREATMENT SHE WILL HAVE NOT DONE IT. PATIENT REPORTED THAT 10 DAYS AFTER TREATMENT EYES WERE VERY WATERY AND THAT 2 WEEKS POST TREATMENT STARTED FEELING PAIN IN BOTH EYES (LEFT WAS WORSE). PATIENT CLAIM HER EYES WERE GETTING WORSE. THE OFFICE OF THE SURGEON WAS AN HOUR AWAY AND PATIENT WAS NOT CONFIDENT ANYMORE. EMOTIONALLY SHE COULDN'T GO TO SEE HER DOCTOR. HER MOTHER HAD TO HELP WITH ACTIVITIES OF DAILY LIVING (GROCERIES SHOPPING, PICKING UP MEDICATIONS) AND SHE WAS UNABLE TO ATTEND FAMILY GATHERINGS DURING HOLIDAYS OR DRIVING, ETC). ON (B)(6) SHE EMAILED HER DOCTOR. PATIENT WAS USING RESTASIS AND XIIDRA POST TREATMENT. DOCTOR HAD THE PATIENT, PRIOR TO TREATMENT, USING PREDNISONE DROPS TO GET THE EYES IN A BETTER SHAPE BEFORE THE LIPIFLOW TREATMENT AS THEY WERE NOT IN GOOD CONDITION. THEN AFTER TREATMENT, BECAUSE OF THE SYMPTOMS, H

  Patient problems: Erosion; Excessive Tear Production; Pain

  MAUDE report 9954580 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCOUNT REPORTED A PATIENT HAD BRUISING AND SWELLING 8 DAYS AFTER A LIPIFLOW TREATMENT.

  Patient problems: Bruise/Contusion; Swelling

  MAUDE report 8203371 ↗