FDA Adverse Event
Malfunction
Summary report: N
CONSTRELLATION VISION SYSTEM
MDR report key: 3042903
·
Received March 5, 2013
Report
- Report Number
- 2028159-2013-00364
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 8, 2013
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K101285
- 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 REC'D 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT AIR CAME FROM THE INFUSION LINE DURING A VITRECTOMY PROCEDURE. THE CASE WAS ABLE TO BE COMPLETED BY CLAMPING THE AIR LINE. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94650 | CONSTRELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CTR | LXT-JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TOTAL PLUS PAK, 25+5.0 CPM VALVED STD J |