FDA Adverse Event
Injury
Summary report: N
VISX EXCIMER LASER
MDR report key: 2021238
·
Received February 9, 2011
Report
- Report Number
- 3006695864-2011-00001
- Event Type
- Injury
- Date Received
- February 9, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 13, 2011
- Manufacturer
- AMO MANUFACTURING USA LLC
- Product Code
- LZS
- PMA / PMN Number
- K000327
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE AMO FIELD SERVICE ENGINEER INSPECTED THE EXCIMER LASER AT THE CUSTOMER LOCATION AND THE EQUIPMENT WAS FOUND TO BE WITHIN ITS SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE CLINIC REPORTED THEY WERE POSSIBLY SEEING OVER-CORRECTIONS. IN A FOLLOW-UP WITH THE CLINIC THEY INDICATED THAT ALL BUT ONE OF THE PATIENTS HAD IMPROVED VISION. ONE PATIENT IS STILL REPORTING VISION ISSUES. THE CLINIC HAS DECLINED AMO'S REQUEST FOR SPECIFIC PATIENT DATA. IT IS NOT KNOWN IF ANY OF THE PATIENTS LOST ANY BEST CORRECTED VISUAL ACUITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISX EXCIMER LASER | LZS | AMO MANUFACTURING USA LLC | STAR S4 IR, CE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |