FDA Adverse Event
Summary report: N
LIPIFLOW
MDR report key: 16487112
·
Received March 2, 2023
Report
- Report Number
- MW5115426
- Date Received
- March 2, 2023
- Report Date
- February 28, 2023
- Manufacturer
- JOHNSON & JOHNSON/TEARSCIENCE, INC.
- Product Code
- ORZ
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PATIENT TRIED LIPIFLOW A COUPLE OF YEARS AGO AND DID NOT FEEL ANY CHANGE IN THE DRYNESS. LACK OF EFFICACY. (B)(6). HCP DID NOT CONSENT TO FOLLOW UP. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736327 | LIPIFLOW | EYELID THERMAL PULSATION SYSTEM | ORZ | JOHNSON & JOHNSON/TEARSCIENCE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |