BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 1873565 · Received October 12, 2010

    Report

    Report Number
    2020664-2010-00107
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS (AMO)
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO SERVICE TECHNICIAN. THERE WERE NO ISSUES DETECTED WITH THE OPERATION OF THE MACHINE. THE MACHINE WAS FOUND TO MEET AMO SPECIFICATIONS. THE AMO CLINICAL SUPPORT SPECIALIST FOLLOWED UP WITH THE CLINIC AND REPORTED THAT THE SURGEON RECENTLY CHANGED THE TYPE OF VISCOELASTIC HE WAS USING FROM A COHESIVE TO A DISPERSIVE AGENT AND DID NOT CHANGE THE PHACO SETTINGS AND TECHNIQUE TO ALLOW FOR THE DIFFERENCE IN VISCOELASTICS. THE SURGEON REVERTED BACK TO THE ORIGINAL VISCOELASTIC AND REPORTED THAT HE HAS NOT HAD ANY FURTHER ISSUES.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE, THE CLINIC REPORTED EXPERIENCING A POSTERIOR CAPSULE TEAR IN THE PT'S OPERATIVE EYE. THE PT REQUIRED SUTURES AND AN UNPLANNED VITRECTOMY. AN ANTERIOR CHAMBER LENS WAS IMPLANTED. THE CLINIC REPORTED PT RECOVERY WOULD BE SLOW AND SURGICAL OUTCOME IS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESTAR SIGNATURE SYSTEM HQC ABBOTT MEDICAL OPTICS (AMO) NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention