BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION

    MDR report key: 2082991 · Received May 4, 2011

    Report

    Report Number
    2028159-2011-00484
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS INVESTIGATION. THE CUSTOMER'S COMPLAINT HISTORY COULD NOT BE REVIEWED AS THE CUSTOMER'S NAME WAS WITHHELD FOR PRIVACY REASONS. THE COMPLAINT HISTORY FOR THE DISPOSABLE PAK WAS REVIEWED; THIS IS THE THIRD COMPLAINT REPORTED, BUT THE SECOND FOR THIS ISSUE. THE DHR WAS REVIEWED; THIS PRODUCT WAS BUILT AND RELEASED PER SPECIFICATIONS. THE CUSTOMER DID NOT RETAIN A SAMPLE; THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS UNK. WHILE A SAMPLE WAS NOT RETURNED, AN INTERNAL INVESTIGATION HAS BEEN OPENED TO INVESTIGATE THE ISSUE OF BUBBLES IN THE FLUID PATH. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A COMBINED PROCEDURE, THE INFUSION LINE WAS PLACED AND PURGED PRIOR TO THE CATARACT SURGERY. EACH TIME THE INFUSION LINE WAS OPENED; NUMEROUS AIR BUBBLES ENTERED THE EYE. THIS LEAD TO A LOSS OF THE POSTERIOR CAPSULE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention