FDA Adverse Event
Injury
Summary report: N
NOVUS OMNI DUAL 3 PHASE
MDR report key: 419177
·
Received September 27, 2002
Report
- Report Number
- 2914019-2002-00006
- Event Type
- Injury
- Date Received
- September 27, 2002
- Date of Event
- August 23, 2002
- Report Date
- August 28, 2002
- Manufacturer
- LUMENIS
- Product Code
- HQF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FACILITY REPORTED A DR HAD STATED THAT SHOTS FIRED BACK THROUGH THE LASERLINK INTO PT'S RETINA. THE DR HAS CLAIMED HE WAS BURNED IN THE RETINA BY THE LASER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVUS OMNI DUAL 3 PHASE | OPHTHALMIC LASERS | HQF | LUMENIS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |