BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER UV-ABSORBING POSTERIOR CHAMBER 3-PIECE INTRAOCULAR

    MDR report key: 635964 · Received September 15, 2005

    Report

    Report Number
    2023826-2005-01277
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Date of Event
    August 16, 2005
    Report Date
    August 16, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON ATTEMPTED TO IMPLANT 3 PIECE COLLAMER LENS. THE LENS HAPTIC SHEARED OFF WHEN THE LENS WASADVANCED IN THE CARTRIDGE PRIOR TO INSERTION INTO THE EYE. NO PT CONTACT OR INJURY. THIS IS THE SECOND OF THREE LENSES USED FOR THE SAME PT. SEE REPORTS 2023826-2005-01219 & 2023826-2005-01280.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER UV-ABSORBING POSTERIOR CHAMBER 3-PIECE INTRAOCULAR INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR