FDA Adverse Event
Injury
Summary report: N
INFINITY VISION SYSTEM
MDR report key: 589496
·
Received April 7, 2005
Report
- Report Number
- 2028159-2005-00047
- Event Type
- Injury
- Date Received
- April 7, 2005
- Date of Event
- March 3, 2005
- Report Date
- March 9, 2005
- Manufacturer
- ALCON-IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ADD'L INFO RECEIVED 5/19/2005 NOTED PT HAD BEEN TREATED WITH SYSTEMIC STEROIDS; OUTCOME REPORTED AS GOOD.
Description of Event or Problem · 1
COMEAL BURN OCCURRED WHEN HANDPIECE WAS INTRODUCED TO INITIANT PHACO. PATIENT'S EYE WAS BANDAGED FOR FOUR DAYS. BURN LASTED ONE WEEK. OUTCOME REPORTED AS POOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITY VISION SYSTEM | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON-IRVINE TECHNOLOGY CENTER | INFINITY | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |