FDA Adverse Event
Injury
Summary report: N
SERIES TEN THOUSAND COMPACT
MDR report key: 138048
·
Received December 9, 1997
Report
- Report Number
- 2028159-1997-00215
- Event Type
- Injury
- Date Received
- December 9, 1997
- Date of Event
- November 7, 1997
- Report Date
- November 10, 1997
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RPTR NOTED SEVEN SURGERIES ON 11/06/1997. FOUND ENDOPHTHALMITIS IN THREE PTS FIRST DAY POST-OP. PTS STABILIZED AFTER VANCOMYCIN IV. ONE PT CULTURED STREP AND REQUIRED AN INTRAVITREAL INJECTION. FOLLOW-UP INDICATED THAT OTHER TWO PTS CULTURED STREP ALSO, AS WELL AS THE CASSETTE DRAINAGE FLUID FROM THE THREE PTS. PTS APPEAR TO BE RECOVERING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TEN THOUSAND COMPACT Implant | PHACOEMULSIFICATION-ASPIRATION SYSTEM | HQE | ALCON LABORATORIES, INC. | STTC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |