FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 1940130
·
Received December 22, 2010
Report
- Report Number
- 2028159-2010-02481
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 8, 2010
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT DURING PHACOEMULSIFICATION, A PHACO ISSUE WAS EXPERIENCED. TROUBLESHOOTING INCLUDED TIGHTENING THE PHACO TIP, WITHOUT SUCCESS. THE CASE WAS COMPLETED WITHOUT ANY HARM TO THE PT, BUT IT IS NOT KNOWN WHETHER THE SYSTEM AND/OR HAND PIECE WAS SWITCHED OUT. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |