FDA Adverse Event
Injury
Summary report: N
ELLIPS FX PHACO HANDPIECE
MDR report key: 2042092
·
Received March 29, 2011
Report
- Report Number
- 2020664-2011-00012
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 16, 2011
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQC
- PMA / PMN Number
- K981116
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS 5 ELLIPSE FX PHACO HANDPIECES HOWEVER, IT IS NOT KNOWN WHICH HANDPIECE WAS INVOLVED WITH THE EVENT. THE HANDPIECE SERIAL NUMBERS ARE AS FOLLOWS: (B)(4), (B)(4), (B)(4), (B)(4), AND (B)(4). THE CUSTOMER WILL NOT BE RETURNING THE HANDPIECES FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE DOCTOR REPORTED OBSERVING IRIS LESIONS FOLLOWING CATARACT SURGERY WITH THE ELLIPSE FX HANDPIECES IN THE OPERATIVE EYES OF TWO PTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELLIPS FX PHACO HANDPIECE | HQC | ABBOTT MEDICAL OPTICS | 690880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |