FDA Adverse Event
Injury
Summary report: N
VISX EXCIMER LASER
MDR report key: 2518133
·
Received January 8, 2010
Report
- Report Number
- 3006695864-2009-00120
- Event Type
- Injury
- Date Received
- January 8, 2010
- Date of Event
- July 12, 2007
- Report Date
- May 15, 2008
- Manufacturer
- AMO MANUFACTURING USA LLC
- Product Code
- LZS
- PMA / PMN Number
- K000327
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN AMO FIELD SERVICE TECHNICIAN EXAMINED THE OPTICAL ALIGNMENT AND SYSTEM PARAMETERS OF THE LASER AND ALL FUNCTIONS WERE WITHIN THE SPECIFICATIONS.
Description of Event or Problem · 1
THE SURGEON REPORTED AN INDUCED ASTIGMATISM AND OVER-CORRECTION IN A PATIENT TREATED FOR LASIK VISION CORRECTION. AT THE THREE MONTH POST OPERATIVE EXAM THE PATIENT PRESENTED WITH A BEST CORRECTED VISUAL ACUITY (BCVA) OF 20/50 OS AND 20/30 OD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISX EXCIMER LASER | LZS | AMO MANUFACTURING USA LLC | STAR S4 IR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |