FDA Adverse Event
Injury
Summary report: N
VISX EXCIMER LASER
MDR report key: 2161948
·
Received April 21, 2011
Report
- Report Number
- 3006695864-2011-00027
- Event Type
- Injury
- Date Received
- April 21, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 31, 2011
- Manufacturer
- AMO MANUFACTURING USA, LLC
- Product Code
- LZS
- PMA / PMN Number
- P930016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE ADVERSE EVENT WAS REPORTED AS PART OF AN INVESTIGATION STUDY FOLLOW-UP. NO SERVICE OR INSPECTION WAS REQUESTED OR IS REQUIRED FOR THE EQUIPMENT. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
A CLINICAL STUDY PATIENT PRESENTED AT THE ONE WEEK POST-OPERATIVE EXAM FOR LASER VISION CORRECTION WITH A DECENTERED FLAP IN THE RIGHT EYE. THE PATIENT'S VISUAL ACUITY IN THE RIGHT EYE AT THE ONE MONTH POST-OPERATIVE VISIT WAS 20/50 UNCORRECTED AND 20/30 CORRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISX EXCIMER LASER | LZS | AMO MANUFACTURING USA, LLC | STAR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other | INTRALASE FEMTOSECOND LASER |