FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 606840
·
Received May 23, 2005
Report
- Report Number
- 2028159-2005-00072
- Event Type
- Injury
- Date Received
- May 23, 2005
- Report Date
- April 22, 2005
- Manufacturer
- ALCON-IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER NOTED CAPSULAR OCCURRED DURING PROCEDURE. PT HAS BEEN REFERRED TO VIT-RET SURGEON DUE TO SUBSEQUENT RETINAL DETACHMENT. CONDITION REPORTED AS UNSATISFACTORY.
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 |