BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3854366 · Received June 6, 2014

    Report

    Report Number
    2023826-2014-00437
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®) WITH TORIC. (B)(4).

    Additional Manufacturer Narrative · 1

    LAF CARD WAS RECEIVED WITH THE PATIENT INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THIS WAS THE FIRST TIME THIS SURGEON USED THE AA4203TL SILICONE SINGLE PIECE LENS AND THE OPTIC TORE AS HE WAS INSERTING IT. THE LENS WAS CUT AND REMOVED WITH FORCEPS WITHOUT ANY DAMAGED TO THE EYE. IT WAS DETERMINED THAT THE INITIAL INCISION WAS NOT LARGE ENOUGH TO ACCOMODATE THE LENS. THE INCISION WAS SLIGHTLY ENLARGED BEFORE THE REPLACEMENT LENS WAS IMPLANTED. THE CAUSE OF THE EVENT WAS A SURGEON'S ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332465 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention MSI-TR INJECTOR MODEL, LOT NUMBER UNKNOWN| MTC-60CFP CARTRIDGE MODEL, LOT NUMBER UNKNOWN