BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3833419 · Received May 27, 2014

    Report

    Report Number
    2023826-2014-00389
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 1, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE®). (B)(4). EVALUATION CODES: METHOD - (OTHER) - LENS WORK ORDER SEARCH RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC IS TORN IN HALF. ONE LOOP HAPTIC AND PIECE OF OPTIC IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT FOUND WITHIN THE SAME WORK ORDER. CONCLUSION - (OTHER): AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM WAS PERFORMED. THE INVESTIGATION 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 INVESTIGATION 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

    THE REPORTER STATED THE SURGEON USED AN AQ5010V THREE PIECE SILICONE LENS. THE LENS WAS LOADED BY THE TECH. AS THE SURGEON ADVANCED THE LENS TO INSERT INTO THE EYE, HE NOTICED THE HAPTIC HAD TORN OFF AND DECIDED NOT TO USE THE LENS. THE LENS WAS NOT INSERTED INTO THE EYE, BUT THERE WAS PATIENT CONTACT. THERE WAS NO PATIENT INJURY. A BACKUP LENS, SAME MODEL AND DIOPTER SIZE WAS IMPLANTED WITH NO ISSUES. THE CAUSE OF TORN HAPTIC IS UNKNOWN. PATIENT INFORMATION NOT AVAILABLE. NO CARTRIDGE OR INJECTOR MODEL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310593 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ5010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL AND LOT NUMBER - UNKNOWN| INJECTOR MODEL AND LOT NUMBER - UNKNOWN