FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 3912831
·
Received May 14, 2014
Report
- Report Number
- 2028159-2014-00888
- Event Type
- Malfunction
- Date Received
- May 14, 2014
- Date of Event
- April 29, 2014
- Report Date
- April 29, 2014
- Manufacturer
- ALCON - IRVINE TECH CTR
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED PRIOR TO STARTING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE FOOTSWITCH PRESENTED PROBLEMS AND THE SYSTEM LOCKED. THE SURGERY WAS COMPLETED USING AN ALTERNATE SYSTEM. THERE WAS NO IMPACT TO SCHEDULED PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288229 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECH CTR | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INFINITI FOOTSWITCH |