inforMED
MalfunctionORZ

LIPIFLOW

Received Apr 6, 2014 · Event occurred Dec 13, 2013

Report MW5035573 · MDR key 3738463

Device

Generic name

Lipiflow

Manufacturer

Tearscience

Product problems

  • Defective Device
  • Device Operates Differently Than Expected

Patient

50 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

I UNDERWENT THE LIPIFLOW TREATMENT TWICE IN 2013, IN (B)(6) 2013 AND MORE RECENTLY IN (B)(6) 2013. AT THE FIRST LIPIFLOW PROCEDURE IN (B)(6) 2013, CONDUCTED AT (B)(6), I CLEARLY FELT THE HEATING OF THE EYELIDS, THE MESSAGING OF THE EYELIDS, ETC. THE PROCEDURE SUCCESSFULLY CLEARED MY MEIBOMIAN GLANDS FOR A NUMBER OF MONTHS. DURING MY MOST RECENT TREATMENT IN (B)(6) 2013, I DID NOT FEEL ANY OF THESE THINGS. I TOLD THE PHYSICIAN DURING THE PROCEDURE THAN I DID NOT FEEL THAT ANYTHING WAS HAPPENING, BUT SHE JUST SAID THAT I COULD NOT FEEL ANYTHING BECAUSE MY EYES WERE NUMB. AFTER THE PROCEDURE, I DID NOT FEEL OR NOTICE ANY CHANGE, EITHER SHORT TERM OR LONG TERM. GIVEN MY PRIOR EXPERIENCE WITH LIPIFLOW. I STRONGLY BELIEVE THAT THE LIPIFLOW MACHINE WAS DEFECTIVE OR DID NOT WORK APPROPRIATELY DURING MY MOST RECENT PROCEDURE. THE PHYSICIAN, DR (B)(6), AGREED THAT THE MOST RECENT TREATMENT WAS A FAILURE, AND OFFERED A 'DO OVER' FOR A REDUCED PRICE. HOWEVER, GIVEN THAT I HAVE NO CONFIDENCE THAT HER MACHINE IS EFFECTIVE AT ALL, I AM NOT INTERESTED IN REPEATING THE PROCEDURE AT HER PRACTICE AT ANY PRICE. MY MOST RECENT LIPIFLOW TREATMENT APPEARS TO BE AN OPERATIONAL FAILURE OF SOME SORT. AS MENTIONED, I FELT NOTHING AT ALL EITHER DURING OR AFTER THE PROCEDURE. THIS WAS IN CLEAR CONTRAST TO THE FIRST TIME I UNDERWENT THE PROCEDURE. I AM WRITING BECAUSE PRESUMABLY THERE SHOULD NOT BE THESE OPERATIONAL DIFFERENCES IN LIPIFLOW PROCEDURES ACROSS PRACTICED. I ASSUMED THAT THE LIPIFLOW TREATMENT WOULD BE QUALITATIVELY SIMILAR FROM ONE MACHINE TO ANOTHER. THIS IS CLEARLY NOT THE CASE. I FULLY REALIZE THAT THE OUTCOME OF LIPIFLOW IS NOT GUARANTEED. HOWEVER, THE UNDERLYING INTEGRITY OF THE MACHINE SHOULD NOT VARY ACROSS PRACTICES.