FDA Adverse Event
Injury
Summary report: N
UNIVERSAL MVS
MDR report key: 512412
·
Received February 19, 2004
Report
- Report Number
- 2028159-2004-00037
- Event Type
- Injury
- Date Received
- February 19, 2004
- Report Date
- January 20, 2004
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER NOTED FOUR CASES OF ENDOPHTHALMITIS 3+ DAYS POST-OP AT THIS CLINIC IN 2003. PT 1 OF 4: 15 DAYS POST-OP. PT HAD PAIN, HYPOPYON, HYALITIS, CORNEAL EDEMA. CULTURED ANTERIOR CHAMBER: STREPTOCOCCUS MITIS. TREATED WITH INTRAVITREAL ANTIBIOTICS. PROGNOSIS IS POOR; COUNT FINGERS AT A 2 METER DISTANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL MVS | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON - IRVINE TECHNOLOGY CENTER | UNIVERSAL MVS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |