InjuryORZ
TEARSCIENCE LIPIFLOW THERMAL PULSATION SYSTEM
Received Jan 24, 2022 · Event occurred May 20, 2021
Report MW5106932 · MDR key 13343292
Device
Generic name
Eyelid Thermal Pulsation System
Manufacturer
Johnson & Johnson Vision / Tearscience, Inc.Product problems
- Patient-Device Incompatibility
Patient
42 YR · Male
- Inflammation
- Pain
- Inflammation
- Pain
Narrative
Description of Event or Problem
GOT THE LIPIFLOW TREATMENT DONE IN BOTH EYES. THIS WAS DONE USING TEARSCIENCE LIPIFLOW THERMAL PULSATION SYSTEM. RESULTED IN SEVERE INFLAMMATION IN BOTH EYES. NOW, BECAUSE OF THE SEVERE INFLAMMATION AND SUBSEQUENT TREATMENTS INCLUDING MULTIPLE ROUNDS OF STEROIDS, I HAVE DEVELOPED CONJUNCTIVAL CHALASIS IN BOTH EYES. VERY PAINFUL. FDA SAFETY REPORT ID# (B)(4).