BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER UV-ABSORBING POSTERIOR CHAMBER 3-PIECE INTRAOCULAR

    MDR report key: 736819 · Received July 1, 2005

    Report

    Report Number
    2023826-2005-00848
    Event Type
    Malfunction
    Date Received
    July 1, 2005
    Date of Event
    June 1, 2005
    Report Date
    June 2, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON ATTEMPTED TO IMPLANT A CQ2015 3 PIECE COLLAMER LENS. THE LENS TRAILING HAPTIC TORE PRIOR TO INSERTION INTO THE EYE. NO PT INJURY. IT WAS UNKNOWN WHAT CAUSED THE TRAILING HAPTIC TO TEAR. THE INJECTOR MODEL THAT WAS USED WAS A ONYX-P, LOT NUMBER 1200954. THE CARTRIDGE MODEL THAT WAS USED WAS A ONYX CARTRIDGE FP, LOT NUMBER 1199802.

    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 UNKNOWN