FDA Adverse Event
Malfunction
Summary report: N
LENSX LASER SYSTEM
MDR report key: 2972466
·
Received February 15, 2013
Report
- Report Number
- 3008772169-2013-00011
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 18, 2013
- Report Date
- January 18, 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
- SP
- 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
TECHNICAL SERVICES REPORTED THAT DURING ROUTINE MAINTENANCE THE GANTRY WAS NOTED TO MOVE DOWNWARD WITHOUT EXTRA WEIGHT BEING APPLIED TO IT. NO PT WAS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69526 | LENSX LASER SYSTEM | OPHTHALMIC FEMTOSECOND LASER | OOE | ALCON - LENSX LASERS, INC. | 550 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |