BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE

    MDR report key: 709055 · Received May 5, 2006

    Report

    Report Number
    2023826-2006-00581
    Event Type
    Injury
    Date Received
    May 5, 2006
    Date of Event
    April 5, 2006
    Report Date
    April 5, 2006
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON INSERTED AN AQ2003V SILICONE THREE PIECE LENS AND THE LENS TORE UPON INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER LENS WAS INSERTED. THIS THE FIRST OF THREE LENES USED ON THIS PATIENT. SEE MFR REPORT NUMBERS 2023826-2006-000582 AND 2023826-2006-000583.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention