FDA Adverse Event
Malfunction
Summary report: N
LENSX LASER SYSTEM
MDR report key: 2945240
·
Received February 1, 2013
Report
- Report Number
- 3008772169-2013-00006
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- January 3, 2013
- Report Date
- January 3, 2013
- Manufacturer
- ALCON - LENSX LASERS INC.
- Product Code
- OOE
- PMA / PMN Number
- K101626
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
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. (B)(4).
Description of Event or Problem · 1
WHILE ON SITE TO SERVICE THE LASER, THE COMPANY FSE (FIELD SERVICE ENGINEER) NOTED THAT THE GANTRY MOVED DOWNWARD ON ITS OWN WHEN THERE WAS NO POWER TO THE SYSTEM. THERE WAS NOT PT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44439 | LENSX LASER SYSTEM | OPHTHALMIC FEMTOSECOND LASER | OOE | ALCON - LENSX LASERS INC. | 550 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |