FDA Adverse Event
Injury
Summary report: N
LENSX LASER SYSTEM
MDR report key: 3221808
·
Received July 9, 2013
Report
- Report Number
- 3008772169-2013-00046
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 10, 2013
- Manufacturer
- ALCON - LENSX LASERS, INC.
- Product Code
- OOE
- PMA / PMN Number
- K101626
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LASER AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. BASED ON AVAILABLE INFORMATION, THE CAUSE WAS LIKELY DUE TO USER-DRIVEN LASER SETTINGS THAT WERE NOT YET OPTIMIZED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED AN INCOMPLETE LENS FRAGMENTATION DURING THE LASER ASSISTED LENS FRAGMENTATION. A COMPANY REPRESENTATIVE REPORTED SURGEON HAD DIFFICULTY REMOVING LENS DURING WHICH THE CAPSULE TORE, ANTERIOR TO POSTERIOR, REQUIRING A VITRECTOMY. AN ANTERIOR CHAMBER LENS WAS IMPLANTED. THE EVENT RESOLVED WITH TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312661 | LENSX LASER SYSTEM | OPHTHALMIC FEMTOSECOND LASER | OOE | ALCON - LENSX LASERS, INC. | 550 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | INFINITY |