FDA Adverse Event
Other
Summary report: N
LENSAR LASER SYS -FS 3D
MDR report key: 3935938
·
Received June 16, 2014
Report
- Report Number
- 3009026057-2014-00010
- Event Type
- Other
- Date Received
- June 16, 2014
- Date of Event
- May 30, 2014
- Report Date
- June 16, 2014
- Manufacturer
- LENSAR INC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
A DIST CLINICAL APPLICATION SPECIALIST REPORTED ON (B)(6) 2014 THAT A RADIAL TEAR OCCURRED WHEN THE DOCTOR WAS HYDRO-DISSECTING. THE DOCTOR PROCEEDED TO PERFORM AN ANTERIOR VITRECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353497 | LENSAR LASER SYS -FS 3D | LENSAR LASER SYS -FS 3D | OOE | LENSAR INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |