FDA Adverse Event
Injury
Summary report: N
STAR S4 IR EXCIMER LASER
MDR report key: 2802916
·
Received October 24, 2012
Report
- Report Number
- 3006695864-2012-00169
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- September 28, 2012
- Report Date
- September 28, 2012
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- LZS
- PMA / PMN Number
- P930016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE AMO FIELD SERVICE SPECIALIST INSPECTED THE SYSTEM AT THE CUSTOMER'S LOCATION AND PERFORMED CALIBRATIONS AND ALIGNMENTS. THE SYSTEM WAS FOUND TO BE OPERATING PER ITS SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
Additional Manufacturer Narrative · 1
THE CLINIC REPORTED THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY IN ANY PATIENTS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
Description of Event or Problem · 1
THE CLINIC REPORTED THEY WERE GETTING OVERCORRECTIONS AND REQUESTED A SYSTEM INSPECTION. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAR S4 IR EXCIMER LASER | EXCIMER LASER | LZS | ABBOTT MEDICAL OPTICS | STAR S4 IR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |