BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3081415 · Received April 26, 2013

    Report

    Report Number
    2023826-2013-00313
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    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

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC). (B)(4) - NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT; TORN MATERIAL. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED A HAPTIC WAS TORN AND A CLEAR SURGICAL RESIDUE ON THE LENS. CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED, WHICH WAS SUBSEQUENTLY CLOSED. THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MANUFACTURING OF THE INJECTORS AND CARTRIDGES. PROCESSES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. THE CAPA ALSO ADDRESSED HANDLING ERRORS. ALL INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS. BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND HANDLING ERRORS BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC OF AN AA4203TL SILICONE SINGLE PIECE LENS TORE OFF AS THE LENS WAS INSERTED INTO THE EYE. THE LENS WAS REMOVED WITHOUT ENLARGING THE INCISON AND ANOTHER SAME MODEL/SAME DIOPTER LENS WAS IMPLANTED WITHOUT ANY PATIENT INJURY. THE CAUSE OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182356 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CARTRIDGE MODEL MTC-60CFP, LOT NUMBER UNKNOWN| INJECTOR MODEL MSI-TR, LOT NUMBER UNKNOWN