BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1813024 · Received August 12, 2010

    Report

    Report Number
    2023826-2010-00791
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 4, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIDN'T LIKE HOW LENS LOOKED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS BUT DIDN'T LIKE THE WAY THE LENS LOOKED. THE LENS WAS PARTIALLY INSERTED AND WAS REMOVED WITH NO PT INJURY, NO INCISION ENLARGEMENT OR SUTURES. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE EVENT WAS DUE TO THE LENS NOT HAVING BEEN LOADED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL NANOPOINT, LOT NUMBER - UNK| CARTRIDGE : MODEL NANOPOINT, LOT NUMBER - UNK