BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1870360 · Received October 5, 2010

    Report

    Report Number
    2023826-2010-01010
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 8, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. LENS TORE UPON INSERTION INTO THE EYE. LENS WAS REMOVED WITH NO PATIENT INJURY. NO WIDEN INCISION AND NO SUTURES REQUIRED. REPORTER STATED, LENS TORE DUE TO LOADING ERROR. BACKUP LENS WAS IMPLANTED, SAME MODEL AND SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INJECTOR: MODEL #MSI-PM, LOT #UNK| CARTRIDGE: MODEL #CQ CARTRIDGE-FP, LOT #UNK