BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 4233153 · Received November 6, 2014

    Report

    Report Number
    2023826-2014-00938
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNKNOWN. BRAND NAME: SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®) WITH TORIC. (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RECEIVED IN 2 PIECES AND A HAPTIC AND PART OF THE OPTIC WAS TORN OFF AND MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TRAILING HAPTIC OF THE AA4203TL SILICONE SINGLE PIECE LENS TORE OFF AS THE LENS WAS INSERTED INTO THE EYE. IT HAPPENED TWICE DURING THIS PATIENT'S SURGERY SO THEY CHANGED TO A NEW INJECTOR AND THE THIRD LENS WAS SUCCESSFULLY IMPLANTED WITH NO PATIENT INJURY. THE REPORTER STATED THEY HAD REUSED THE INJECTOR AT LEAST THE RECOMMENDED 20 TIMES AND CONCLUDED EXCESSIVE REUSE OF THE DEVICE CAUSED THE LENS DAMAGE. SEE MFR#2023826-2014-00939 FOR THE OTHER EVENT INVOLVING THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715064 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR MSI-PR INJECTOR MODEL, LOT NUMBER UNKNOWN| MTC-60CFP CARTRIDGE MODEL, LOT NUMBER UNKNOWN