BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1932169 · Received December 8, 2010

    Report

    Report Number
    2023826-2010-01238
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION - (OTHER): THE PRODUCT PERTAINING TO THIS EVENT WAS THROWN AWAY. BASED ON THE COMPLAINT HISTORY, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO LOADING ERROR. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS. LENS WAS REMOVED DUE TO TORN LENS. NO PT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. REPORTER STATED THE LENS TEAR WAS DUE TO LOADING ERROR. THE LENS WAS ACCIDENTLY THROWN AWAY.

    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