FDA Adverse Event
Other
Summary report: N
LENSAR LASER SYSTEM -FS 3D
MDR report key: 3908591
·
Received June 11, 2014
Report
- Report Number
- 3009026057-2014-00011
- Event Type
- Other
- Date Received
- June 11, 2014
- Date of Event
- June 3, 2014
- Report Date
- June 11, 2014
- Manufacturer
- LENSAR INC.
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FROM THE INVESTIGATION WAS DETERMINED THAT THE ARC CUT INCISIONS AND THE CLEAR CORNEAL INCISIONS OVERLAPPED BY 14 DEGREES. ROOT CAUSE: OPERATOR ERROR.
Description of Event or Problem · 1
ON (B)(6) 2014, A DOCTOR NOTED A PERFORATION IN THE TEMPORAL AI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346243 | LENSAR LASER SYSTEM -FS 3D | LENSAR LASER SYSTEM -FS 3D | OOE | LENSAR INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |