FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 619331
·
Received July 1, 2005
Report
- Report Number
- 2028159-2005-00106
- Event Type
- Injury
- Date Received
- July 1, 2005
- Date of Event
- May 25, 2005
- Report Date
- June 2, 2005
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER NOTED SEVERAL CASES FO ENDOPHTHALMITIS FOLLOWING CATARACT SURGERY OVER PAST YEAR. CASES WERE AT END OF DAY; TWO SURGEONS INVOLVED. WANTED PHACO HANDPIECES CHECKED FOR POSSIBLE DEBRIS REMAINING AFTER CLEANING PROCESS. PATIENT 4 OF 5: SURGERY DATE WAS 05/2005. CULTURED: STAPH. CURRENT STATUS IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM | OPHTHALMIC SURGERY SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |