FDA Adverse Event
Other
Summary report: N
LENSAR LASER SYSTEM -FS 3D
MDR report key: 3865828
·
Received May 19, 2014
Report
- Report Number
- 3009026057-2014-00005
- Event Type
- Other
- Date Received
- May 19, 2014
- Date of Event
- April 22, 2014
- Report Date
- May 19, 2014
- Manufacturer
- LENSAR INC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
ON (B)(6) 2014 WHILE A LENSAR CLINICAL APPLICATION SPECIALIST WAS ON SITE FOR A TRAINING A SMALL CAPSULAR TEAR WAS NOTICED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296718 | LENSAR LASER SYSTEM -FS 3D | LENSAR LASER SYSTEM -FS 3D | OOE | LENSAR INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |