MAUDE MDR 7689338

MDR report key
7689338
Report number
MW5078403
Event key
0
Event type
3
Date of event
2017-08-08
Date received
2018-07-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIPIFLOWLIPIFLOWTEARSCIENCE, INC.ORZI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-1301. S

Event Narratives#

D

Patient 1

MY DOCTOR RECOMMENDED THAT I PURSUE THE LIPIFLOW PROCEDURE TO REMOVE THE BLOCKAGE IN THE MEIBOMIAN GLANDS IN THE EYELIDS THAT PRODUCE THE PROTECTIVE OILY LAYER OF THE TEAR FILM. BEFORE I AGREED TO THIS MEDICAL DEVICE PROCEDURE, A COMPANY REPRESENTATIVE TOOK A PHOTO OF MY GLANDS THAT CLEARLY SHOWED SOME BLOCKAGE. BEFORE I ELECTED TO HAVE THE LIPIFLOW PROCEDURE THE DOCTOR SUGGESTED I TRY OTC LUBRICANT EYE DROPS. THESE EYE DROPS WERE NOT EFFECTIVE IN REDUCING THE DRY EYE CONDITION THAT IS NORMALLY PRODUCED BY THE MEIBOMIAN GLANDS. THE LIPIFLOW PROCEDURE INVOLVES THE USE OF A MEDICAL DEVICE PLACED OVER EACH EYE AND PERFORMS AN APPLICATION REFERRED TO ?VECTORED THERMAL PULSATION?. THE ENTIRE PROCEDURE TOOK LESS THAN 10 MINUTES. I WAS TOLD BY THE DOCTOR?S TECHNICIAN THAT SUCCESS WOULD TAKE SEVERAL WEEKS TO REFLECT ANY NOTICEABLE IMPROVEMENT IN MY DRY EYE CONDITION. AS THE WEEKS AND MONTHS PASSED, I KEPT IN CONTACT WITH DOCTOR AND HE DID NOT UNDERSTAND WHY I DID NOT RECEIVE ANY RELIEF. THE PROCEDURE COST (B)(6) AND INSURANCE DID NOT COVER ANY PORTION OF THE COST. I CANNOT FIND ANY SPECIFIC NAME FOR THE DEVICE USED TO CONDUCT THE LIPIFLOW APPLICATION.