MAUDE Adverse Event Report: ALCON RESEARCH, LLC SYSTANE; EYELID THERMAL PULSATION SYSTEM

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Lack of efficacy.

• Brand Name: SYSTANE
• Type of Device: EYELID THERMAL PULSATION SYSTEM
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 11505444
• MDR Text Key: 240736333
• Report Number: MW5100026
• Device Sequence Number: 1
• Product Code: ORZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Patient Sequence Number: 1
• Patient Outcome(s): Other