BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2103176 · Received May 25, 2011

    Report

    Report Number
    2023826-2011-00461
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN, WITH A PIECE TORN OFF AND MISSING. ONE HAPTIC WAS BENT. THE LENS WAS RETURNED IN LIQUID. CONCLUSIONS: BASES ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A LIKELY ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO THE OFF-LABEL USE OF THE INJECTION SYSTEM WITH THIS MODEL LENS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC THREE PIECE LENS AND THE HAPTIC TORE. THERE WAS PATIENT CONTACT BUT NO INJURY. THE REPORTER STATED THE FACILITY USES A COMPETITOR'S INJECTION SYSTEM WITH THIS MODEL LENS WHICH IS OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CQ2015A

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR