BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3243911 · Received July 23, 2013

    Report

    Report Number
    2023826-2013-00619
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC). CONCLUSION: BASED ON THE COMPLAINT HISTORY, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RECEIVED IN TWO PIECES AND A PART OF THE HAPTIC WAS TORN OFF AND MISSING. THE PLUNGER OF THE INJECTOR WAS BROKEN AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE AA4204VL SILICONE SINGLE PIECE LENS WAS LOADED, THE TECH WAS PRIMING IT THROUGH THE INJECTOR, WHICH BROKE AND TORE THE LENS. THERE WAS NO PATIENT CONTACT. CUSTOMER STATED THE INCIDENT WAS DUE TO A THE BROKEN INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344486 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4204VL N/A

    Patients

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