BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 591645 · Received April 15, 2005

    Report

    Report Number
    2023826-2005-00470
    Event Type
    Injury
    Date Received
    April 15, 2005
    Date of Event
    March 14, 2005
    Report Date
    March 18, 2005
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A CC4204BF COLLAMER PLATE LENS BUT IT TORE AS IT WAS BEING INSERTED. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE REQUIRED. THE FACILITY STATED THAT IT IS UNKNOWN WHAT CAUSED THE LENS TEAR. AN INDIGO-P INJECTOR AND AN SFC-25 FP CARTRIDGE WERE USED BUT THE FACILITY WAS UNABLE TO PROVIDE THE LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention