BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 7535153 · Received May 22, 2018

    Report

    Report Number
    2023826-2018-00770
    Event Type
    Injury
    Date Received
    May 22, 2018
    Report Date
    April 27, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    UDI-DI
    00841542102391
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: LENS WAS RETURNED IN LIQUID, IN LENS CASE/VIAL. VISUAL INSPECTION FOUND NO VISIBLE LENS DAMAGE TO THE LENS. RETURNED TO MANUFACTURER DATE: 03-MAR-2018. WORK ORDER SEARCH: CORRECTED TO: "NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT". (B)(4)

    Description of Event or Problem · 1

    A COMPLETED LAF CARD FOR A CC4204A, +20.0 DIOPTER, INTRAOCULAR LENS WAS RETURNED BACK TO THE MANUFACTURER. NOTE ON THE LAF CARD INDICATED "EXPLANTED". NURSE AT THE FACILITY STATED THAT SHE COULD NOT FIND ANY INFORMATION ON THIS LENS, THERE WAS NO DOCUMENTATION. THE ONLY INFORMATION AVAILABLE WAS THAT A THREE PIECE LENS WAS USED INSTEAD. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376873 SEE H10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA 00841542102391

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention