FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 635412
·
Received September 15, 2005
Report
- Report Number
- 2028159-2005-00147
- Event Type
- Injury
- Date Received
- September 15, 2005
- Date of Event
- August 11, 2005
- Report Date
- August 16, 2005
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER NOTED PROBLEMS DURING SURGERY IN THREE CASES. CASSETTES AND HANDPIECES WERE EXCHANGED UNTIL SYSTEM WORKED. TWO PATIENTS HAD NO CONSEQUENCES. ONE PATIENT HAD CORNEAL BURN (OD) DURING PROCEDURE; ONE SUTURE USED TO CLOSE WOUND. ALSO HAD IRIS PROLAPSE. ADDITIONAL INFORMATION RECEIVED IN 08/2005 NOTED PROCEDURE TO REPAIR IRIS WOULD BE DONE THAT DAY. SUTURE WAS REMOVED AT TIME OF SECOND EYE (OS) SURGERY. OUTCOME REPORTED AS GOOD.
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 | Required Intervention |