FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYS
MDR report key: 4173201
·
Received October 10, 2014
Report
- Report Number
- 2028159-2014-01865
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 15, 2014
- 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
- CT, US
- 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 SURGICAL TECHNICIAN REPORTED THAT A RED STOP SIGN DISPLAYED AND THAT THERE WERE FOOTSWITCH ISSUES. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643039 | CONSTELLATION VISION SYS | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CTR | LXT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |