FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 3960189
·
Received June 24, 2014
Report
- Report Number
- 2028159-2014-01195
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Date of Event
- May 29, 2014
- Report Date
- May 30, 2014
- Manufacturer
- ALCON MANUFACTURING, LTD.
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. 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 INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
AN OPTHALMIC SURGEON REPORTED THAT POOR ASPIRATION OCCURRED DURING SURGERY. THE SURGEON USED A REPLACEMENT AND PROCEEDED, THE PROCEDURE WAS COMPLETED WITHOUT HARM OR IMPACT TO THE PATIENT. ADDITIONAL INFORMATION IS NOT EXPECTED TO BE OBTAINED FOR THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367380 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON MANUFACTURING, LTD. | INFINITI OZIL JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INTREPID PLUS PAK 0.9MM J |