FDA Adverse Event
Injury
Summary report: N
SERIES TEN THOUSAND MASTER
MDR report key: 178737
·
Received July 24, 1998
Report
- Report Number
- 2028159-1998-00211
- Event Type
- Injury
- Date Received
- July 24, 1998
- Date of Event
- June 1, 1998
- Report Date
- June 26, 1998
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER NOTED ENDOPHTHALMITIS; INTRAVITREAL ANTIBIOTIC INJECTED, AND PATIENT WAS REFERRED TO RETINAL SPECIALIST. INTRAOCULAR LENS WAS EXPLANTED ON 6/24/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TEN THOUSAND MASTER | PHACOEMULSIFICATION-ASPIRATION SYSTEM | HQE | ALCON LABORATORIES, INC. | STTM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |