BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 6176009 · Received December 15, 2016

    Report

    Report Number
    2023826-2016-01761
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 14, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    UDI-DI
    00841542102407
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS TORN INTO THREE PIECES, WITH PIECES TORN OFF AND MISSING. THERE WERE SCRATCHES AND TEARS ON THE LENS OPTIC AND HAPTICS. THE LENS WAS RETURNED IN LIQUID. (B)(4).

    Additional Manufacturer Narrative · 1

    COLLAMER® ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +20.5 DIOPTER, AND NOTED A SCRATCH ON THE LENS. THE INCISION WAS ENLARGED SLIGHTLY TO REMOVE THE LENS WITHIN THE SAME SURGERY AND THE BACKUP LENS WAS IMPLANTED. THE LENS WAS ALSO CUT TO REMOVE FROM THE EYE. THE REPORTER STATED IT WAS UNKNOWN IF SUTURES WERE REQUIRED. THE REPORTER STATED THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829725 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA 00841542102407

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention CARTRIDGE MODEL NANOPOINT - LOT NUMBER UNK| INJECTOR MODEL NANOPOINT - LOT NUMBER UNK