FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 372098
·
Received January 17, 2002
Report
- Report Number
- 2028159-2002-00018
- Event Type
- Injury
- Date Received
- January 17, 2002
- Date of Event
- December 12, 2001
- Report Date
- December 18, 2001
- Manufacturer
- ALCON - IRVINCE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER NOTED THREE CASES OF BACTERIAL ENDOPHTHALMITIS WITH SURGEON. PATIENT 2 OF 3: ONSET THREE DAYS POST-OPERATION. CULTURES PENDING. HAD INTRAVITREAL INJECTION OF ANTIBIOTICS. CONDITION REPORTED AS IMPROVING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON - IRVINCE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |