FDA Adverse Event
Injury
Summary report: N
LENSAR LASER SYSTEM-FS 3D
MDR report key: 5522279
·
Received March 24, 2016
Report
- Report Number
- 3009026057-2016-00011
- Event Type
- Injury
- Date Received
- March 24, 2016
- Date of Event
- February 24, 2016
- Report Date
- March 24, 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
- FL, US
- Reporter Occupation
- OTHER
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.
Additional Manufacturer Narrative · 1
SERVICE CALL (B)(4) WAS OPENED TO INVESTIGATE THE REPORTED EVENT. THE USERS ARE TRAINED DURING THE INITIAL CLINICAL TRAINING ABOUT THE USE OF THE DIFFERENT WINDOWS. THERE WERE NO PATIENT INJURIES REPORTED BY THE CLINICAL SITE. (B)(4) WAS ISSUED AND WILL BE SENT TO ALL USERS REVIEWING THE PROPER USE OF CALIBRATION WINDOW AND PID WINDOWS.
Description of Event or Problem · 1
CUSTOMER USED A NON STERILE CALIBRATION WINDOW TO PERFORM A SURGICAL PROCEDURE.
Description of Event or Problem · 1
CUSTOMER USED A NON STERILE CALIBRATION WINDOW TO PERFORM A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179786 | LENSAR LASER SYSTEM-FS 3D | LENSAR LASER SYSTEM-FS 3D | OOE | LENSAR, LLC | 70-00024-001 | 49802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |