FDA Adverse Event
Other
Summary report: N
LENSAR LASER SYSTEM -FS 3D
MDR report key: 4467893
·
Received November 3, 2014
Report
- Report Number
- 3009026057-2014-00028
- Event Type
- Other
- Date Received
- November 3, 2014
- Date of Event
- October 7, 2014
- Report Date
- October 31, 2014
- Manufacturer
- LENSAR INC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS 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 DOCTOR REPORTED TO A LENSAR FIELD SERVICE ENGINEER WHILE ON SITE THAT A TEMPORAL POSTERIOR CAPSULE RUPTURE WAS NOTED AFTER CORTEX REMOVAL . THE DOCTOR PERFORMED A VITRECTOMY AND PLACED THE IOL WITH NO OTHER COMPLICATIONS. THERE WAS NO POST-OP ISSUES AND THE PATIENT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704632 | LENSAR LASER SYSTEM -FS 3D | LENSAR LASER SYSTEM -FS 3D | OOE | LENSAR INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |