FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LAGACY
MDR report key: 298299
·
Received September 28, 2000
Report
- Report Number
- 2028159-2000-00251
- Event Type
- Injury
- Date Received
- September 28, 2000
- Date of Event
- August 25, 2000
- Report Date
- August 30, 2000
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
REPORTER NOTED POSTERIOR CAPSULE TEAR OCCURRED DURING PHACO; ANTERIOR VITRECTOMY PERFORMED AND IOL INSERTED. FELT THERE WAS TOO MUCH VIBRATION AT HIGHER POWER SETTINGS; WANTED SYSTEM CHECKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LAGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON - IRVINE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |