MAUDE Adverse Event Report: UNKNOWN LIPIFLOW; EYELID THERMAL PULSATION SYSTEM

Patient Problems Flashers (1864); Vitreous Floaters (1866)

Event Date 08/09/2023

Event Type  Injury  

Event Description

2 days after having lipiflow and taking lotemax sm i developed light flashes and floaters in my eyes.

• Brand Name: LIPIFLOW
• Type of Device: EYELID THERMAL PULSATION SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17566696
• MDR Text Key: 321525738
• Report Number: MW5144694
• Device Sequence Number: 1
• Product Code: ORZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: RETAINE EYE DROPS.
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American