D
Patient 1
THE TIP INSTRUMENT BROKE OFF IN THE PT'S EYE DURING A CATARACT EXTRACTION PROCEDURE. THE BROKEN PIECE WAS ASPIRATED USING PHACOEMULSIFICATION HANDPIECE.
MAUDE MDR 67197
- MDR report key
- 67197
- Report number
- 1932180-1997-00021
- Event key
- 0
- Event type
- 3
- Date of event
- 1997-01-23
- Date received
- 1997-02-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NICHAMIN DOUBLE ENDED NUCLEUS CHOPPER-SPATULA | CHOPPER/SPATULA | STORZ INSTRUMENT CO | HND | NA | E0570 N | NA | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1997-02-04 | 0 |