FDA Adverse Event
Injury
Summary report: N
LENSAR LASER SYSTEM-FS 3D
MDR report key: 5690752
·
Received June 1, 2016
Report
- Report Number
- 3009026057-2016-00018
- Event Type
- Injury
- Date Received
- June 1, 2016
- Date of Event
- May 2, 2016
- Report Date
- June 1, 2016
- Manufacturer
- LENSAR, LLC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
ON (B)(6) 2016 CUSTOMER REPORTED THAT HAD A POSTERIOR CAPSULE TEAR AND A VITRECTOMY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346268 | LENSAR LASER SYSTEM-FS 3D | LENSAR LASER SYSTEM-FS 3D | OOE | LENSAR, LLC | 70-00005-001 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |