FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 2191374
·
Received July 27, 2011
Report
- Report Number
- 2028159-2011-00856
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 27, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 CUSTOMER REPORTED DURING THE SCULPTING PHASE OF A PHACOEMULSIFICATION PROCEDURE, TINY BUBBLES WERE OBSERVED IN THE EYE OF A PT, WHICH OBSTRUCTED THE SURGEON'S FIELD OF VISION. THE CASE WAS COMPLETED WITHOUT HARM OR INJURY TO THE PT. ADD'L INFO HAS BEEN REQUESTED. THIS IS ONE OF FIVE MEDICAL DEVICE REPORTS FOR THIS FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CTR | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | ULTRASOUND FMS| DUOVISC |