FDA Adverse Event
Malfunction
Summary report: N
INFINIT VISION SYSTEM OZIL
MDR report key: 2900872
·
Received December 12, 2012
Report
- Report Number
- 2028159-2012-01986
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 12, 2012
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP EXAMINED THE SYS AND CONFIRMED THE PROBLEM REPORTED. THE COMPANY REP TIGHTENED THE PNEUMATIC CONNECTOR AS IT WAS FOUND TO BE LOOSE. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYS. THE ROOT CAUSE WAS A NONCONFORMING PNEUMATIC CONNECTOR. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED HAVING DIFFICULTY CONNECTING THE PROBE DURING A PROCEDURE. FOLLOWING A DELAY OF 15 MINUTES, AN ALTERNATE SYS WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINIT VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CTR | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |