FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYS
MDR report key: 4173159
·
Received October 10, 2014
Report
- Report Number
- 2028159-2014-01861
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 10, 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
- IN, 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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT THE C3F8 WAS NOT DELIVERED TO THE AUTO SYRINGE AND THERE WERE PRIMING ISSUES PRIOR TO PROCEDURES. THERE WAS NO PT INVOLVEMENT. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643282 | CONSTELLATION VISION SYS | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CTR | LXT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | C3F8 |