FDA Adverse Event
Malfunction
Summary report: N
LENSAR LASER SYSTEM-FS 3D
MDR report key: 4898689
·
Received June 30, 2015
Report
- Report Number
- 3009026057-2015-00023
- Event Type
- Malfunction
- Date Received
- June 30, 2015
- Date of Event
- June 5, 2015
- Report Date
- June 30, 2015
- Manufacturer
- LENSAR INC
- Product Code
- OOE
- PMA / PMN Number
- K120214
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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
IF A USER PRESSED THE "LASER PARAMETERS" BUTTON (INDICATING A DESIRE TO CHANGE THE PLANNED TREATMENT JUST PRIOR TO SURGERY) BEFORE INITIALLY COMPLETING IRIS REGISTRATION, THERE IS A POSSIBILITY THAT AN INCORRECT CYCLOTORSION VALUE MAY BE GENERATED BY THE COMPARISON OF A NON-CORRESPONDING IRIS REGISTRATION IMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 424028 | LENSAR LASER SYSTEM-FS 3D | LENSAR LASER SYSTEM-FS 3D | OOE | LENSAR INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |