FDA Adverse Event
Malfunction
Summary report: N
SVS APEX PLUS
MDR report key: 164525
·
Received April 24, 1998
Report
- Report Number
- 1287364-1998-00003
- Event Type
- Malfunction
- Date Received
- April 24, 1998
- Date of Event
- March 16, 1998
- Report Date
- April 24, 1998
- Manufacturer
- SUMMIT TECHNOLOGY INC.
- Product Code
- HQF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY WERE ENCOUNTERING OVERCORRECTION IN ONE OR MORE PTS TREATED DURING THE WEEK OF MARCH 16, 1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SVS APEX PLUS | OPTHALMIC LASER | HQF | SUMMIT TECHNOLOGY INC. | UV 325000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |