FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 512050
·
Received February 12, 2004
Report
- Report Number
- 2028159-2004-00033
- Event Type
- Injury
- Date Received
- February 12, 2004
- Date of Event
- January 14, 2004
- Report Date
- January 15, 2004
- Manufacturer
- ALCON-IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
REPORTER INITIALLY NOTED INTERMITTENT TURNING AND VACUUM PROBLEMS. ADDITIONAL INFO RECEIVED NOTED CAPSULE HAS BEEN TRAMPOLINING. POSTERIOR CAPSULE TEAR OCCURRED; PROGNOSIS REPORTED AS GOOD, WITH NO VITREOUS IN ANTERIOR CHAMBER NOTED.
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 |