LIPIFLOW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for LIPIFLOW manufactured by Tearscience, Inc..

Event Text Entries

[114210119] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5078403
• MDR Report Key: 7689338
• Date Received: 2018-07-13
• Date of Report: 2018-07-09
• Date of Event: 2017-08-08
• Date Added to Maude: 2018-07-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LIPIFLOW
• Generic Name: LIPIFLOW
• Product Code: ORZ
• Date Received: 2018-07-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TEARSCIENCE, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2018-07-13