FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 294071
·
Received September 1, 2000
Report
- Report Number
- 2028159-2000-00215
- Event Type
- Injury
- Date Received
- September 1, 2000
- Date of Event
- July 24, 2000
- Report Date
- August 4, 2000
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
RPTR NOTED THREE CASES OF ENDOPHTHALMITIS. THE PTS ALL CULTURED NEGATIVE. ALL HAD A VITREOUS TAP AND ANTIBIOTIC INJECTIONS. THIS PT, WITH ENDOPHTHALMITIS AT SEVEN DAYS POST-OP, REQUIRED A TPPV, AND WILL BE CHECKED AGAIN.
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 | 75 YR | Required Intervention |