BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1945266 · Received December 21, 2010

    Report

    Report Number
    2023826-2010-01289
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 16, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE RPTR INDICATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND THE BACK OF THE LENS WAS TORN. THE LENS WAS REMOVED WITH NO PT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE RPTR STATED THE CAUSE OF THE TORN LENS WAS DUE TO A LOADING ERROR.

    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 CARTRIDGE: MODEL NANOPOINT - LOT NUMBER UNK| INJECTOR: MODEL NANOPOINT - LOT NUMBER UNK