FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3901674
·
Received May 7, 2014
Report
- Report Number
- 2028159-2014-00691
- Event Type
- Malfunction
- Date Received
- May 7, 2014
- Date of Event
- April 6, 2014
- Report Date
- April 8, 2014
- Manufacturer
- ALCON-IRVINE TECH CTR
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A BIOMED TECH REPORTED THAT A SYSTEM RECEIVED A SYSTEM MESSAGE AND A LAMP BURST DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WHEN THEY SWITCHED TO THE AUXILIARY LAMP. THERE WAS NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 276075 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON-IRVINE TECH CTR | LXT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |