BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3013724 · Received March 20, 2013

    Report

    Report Number
    2023826-2013-00223
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE SURGEON INSERTED THE AA4203TL SILICONE ONE PIECE LENS AND THE LENS TORE AS IT WAS INSERTED INTO THE EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER SAME MODEL LENS WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE EVENT WAS THE RESULT OF A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116733 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR MTC-60CFP CARTRIDGE MODEL, LOT NUMBER UNKNOWN