FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 317809
·
Received February 16, 2001
Report
- Report Number
- 2028159-2001-00040
- Event Type
- Injury
- Date Received
- February 16, 2001
- Date of Event
- January 18, 2001
- Report Date
- January 19, 2001
- Manufacturer
- ALCON-IRVINE TECHNOLOGY CTR
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
RPTR NOTED POSTERIOR CAPSULE TEAR DUE TO SUDDEN BURST OF AIR (BUBBLE) IN ANTERIOR CHAMBER DURING PHACO. CLOSED EYE WITHOUT VITRECTOMY OR IOL, AND SENT PT TO RETINAL SPECIALIST. PROGNOSIS: GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6301 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON-IRVINE TECHNOLOGY CTR | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |