BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1031374 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00543
    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

    EVALUATION: RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THE TECHNICIAN NOTED ONE HAPTIC OF A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS WAS BENT UPON REMOVAL FROM THE LENS VIAL. THE TECHNICIAN LOADED THE LENS INTO THE CARTRIDGE BUT AFTER CHECKING WITH THE SURGEON THEY DECIDED NOT TO USE THE LENS. THERE WAS NO PATIENT CONTACT. ANOTHER CQ2015A MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE LENS WAS RECEIVED BENT AND WAS DEFECTIVE.

    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 CARTRIDGE MODEL CQ CARTRIDGE - FP-LOT NUMBER UNK| INJECTOR MODEL: MSI-PM LOT NUMBER: UNK| VISCOELASTIC MODEL STAARVISC II - LOT NUMBER UNK