BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2900870 · Received December 12, 2012

    Report

    Report Number
    2028159-2012-01944
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 13, 2012
    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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND CONFIRMED THE SYS MESSAGE REPORTED. THE PNEUMATICS MODULE WAS REPLACED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYS. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYS MESSAGE DISPLAYED DURING SETUP FOR A PROCEDURE. THE CASE WAS CANCELED. THE PT HAD ALREADY RECEIVED PERIBULBAR ANESTHESIA IN PREPARATION FOR THE SURGERY. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR L NA

    Patients

    Seq Age Sex Outcome Treatment
    1