FDA Adverse Event
Injury
Summary report: N
SUREPASS BLADE
MDR report key: 3310650
·
Received August 15, 2013
Report
- Report Number
- 9614468-2013-00003
- Event Type
- Injury
- Date Received
- August 15, 2013
- Date of Event
- July 8, 2013
- Report Date
- August 15, 2013
- Manufacturer
- SIS LTD. SURGICAL INSTRUMENT SYSTEMS
- Product Code
- HNO
- PMA / PMN Number
- K043150
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PARTICLES OBSERVED ON BOTH EYES AFTER LASIK FLAP CUT USING MICROKERATOME; PARTICLES COULD NOT BE ENTIRELY RINSED OUT; SURGERY COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395134 | SUREPASS BLADE | AMADEUS II | HNO | SIS LTD. SURGICAL INSTRUMENT SYSTEMS | NA | 0812/00/P-35223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |