LIPIFLOW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-06 for LIPIFLOW manufactured by Tearscience.

Event Text Entries

[4278780] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5035573
MDR Report Key3738463
Date Received2014-04-06
Date of Report2014-04-06
Date of Event2013-12-13
Date Added to Maude2014-04-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLIPIFLOW
Generic NameLIPIFLOW
Product CodeORZ
Date Received2014-04-06
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerTEARSCIENCE


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.