FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3960047
·
Received May 29, 2014
Report
- Report Number
- 2028159-2014-00956
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 1, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A PRODUCT SAMPLE HAS BEEN RECEIVED AND IT IS AWAITING EVALUATION. H.3., H.6.: 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 HEALTHCARE PROFESSIONAL REPORTED LIMITED PROBE'S CUTTER SPEED NOTED DURING A RETINAL PROCEDURE. THE REPORTER BELIEVES THAT THE ISSUE IS LIKELY RELATED TO THE COLOR CODES ON THE TUBINGS WHICH WERE NOTICED TO BE INCORRECT. ADDITIONAL INFO HAS BEEN REQUESTED FOR THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315874 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | LXT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONSTELLATION PAK |