FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 285791
·
Received July 13, 2000
Report
- Report Number
- 2028159-2000-00169
- Event Type
- Injury
- Date Received
- July 13, 2000
- Date of Event
- June 13, 2000
- Report Date
- June 13, 2000
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RPTR NOTED THE NUCLEUS WAS ROCK HARD, CONVERTED TO EXTRA-CAPSULAR CATARACT EXTRACT. WHILE DELIVERING THE LENS AND MANIPULATING WITH THE LENS LOOP THE POSTERIOR CAPSULE WAS TORN. ANTERIOR VITRECTOMY DONE AND AC IOL IMPLANTED. PT REPORTEDLY RECOVERING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON - IRVINE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |