BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1031375 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00544
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 27, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS BUT HAPTIC TORE. THERE WAS NO PATIENT CONTACT. ANOTHER CQ2015A MODEL LENS WAS IMPLANTED.

    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 COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL: MSI-PM LOT NUMBER: UNK| VISCOELASTIC MODEL STAARVISC II - LOT NUMBER UNK| CARTRIDGE MODEL CQ CARTRIDGE-FP - LOT NUMBER UNK