FDA Adverse Event
Other
Summary report: N
LENSAR LASER SYSTEM -FS 3D
MDR report key: 4193908
·
Received October 20, 2014
Report
- Report Number
- 3009026057-2014-00029
- Event Type
- Other
- Date Received
- October 20, 2014
- Date of Event
- September 22, 2014
- Report Date
- October 20, 2014
- Manufacturer
- LENSAR INC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- 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 INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
A LENSAR REPRESENTATIVE REPORTED THAT ON THE THIRD AND FOURTH CASES OF THE DAY, THE FRAGMENTATION PATTERN WAS DECENTERED OUTSIDE THE CAPSULE. BOTH PROCEDURES WERE ABORTED AND NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666764 | LENSAR LASER SYSTEM -FS 3D | LENSAR LASER SYSTEM -FS 3D | OOE | LENSAR INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |