BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2170078 · Received June 17, 2011

    Report

    Report Number
    2028159-2011-00699
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE; HOWEVER, THE CUSTOMER DID ORDER A NEW FOOTSWITCH. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL SPECIALITY COORDINATOR REPORTED THAT DURING PARS PLANA VITRECTOMY AND SCLERAL BUCKLE SURGERY, LEFT EYE, AN AIR LOCK IN THE LINE CAUSED THE GLOBE TO COLLAPSE, AND THE FOOTSWITCH WOULDN'T RESPOND TO BEING DEPRESSED. THE INFUSION CANNULA TOUCHED THE CRYSTALLINE LENS CAUSING A LOCALIZED CATARACT. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON'S OFFICE INDICATES THAT ON THE MOST RECENT POSTOPERATIVE VISIT, AT 12 DAYS POST-OP, THE BEST CORRECTED VISUAL ACUITY IN THE SURGICAL EYE WAS COUNT FINGERS. THE SURGEON'S OFFICE DECLINED TO PROVIDE ANY FURTHER INFORMATION REGARDING THE PATIENT'S HISTORY OR PROGNOSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other