FDA Adverse Event
Other
Summary report: N
LENSAR LASER SYSTEM -FS 3D
MDR report key: 4073010
·
Received September 2, 2014
Report
- Report Number
- 3009026057-2014-00020
- Event Type
- Other
- Date Received
- September 2, 2014
- Date of Event
- July 29, 2014
- Report Date
- August 27, 2014
- Manufacturer
- LENSAR INC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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
DOCTOR REPORTED TO A LENSAR DISTRIBUTOR THAT THE CAPSULOTOMY WAS INCOMPLETE RESULTING IN A RADIAL TEAR AROUND THE POSTERIOR CAPSULE REQUIRING THE PLACEMENT OF AN IOL IN THE SULCUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532337 | LENSAR LASER SYSTEM -FS 3D | LENSAR LASER SY -FS 3D | OOE | LENSAR INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |