BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 2926568 · Received January 17, 2013

    Report

    Report Number
    2023826-2013-00064
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    K940593
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND THE LENS OPTIC IS TORN IN HALF. A PIECE OF THE OPTIC IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED IN 06/2005 (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, 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 A 15.00 DIOPTER AQ2003V THREE PIECE SILICONE LENS. THE LENS WAS DAMAGED DURING LOADING PROCESS. NOTICED THE LENS TORE AS LENS WAS BEING PRIMED. THERE WAS NO PT CONTACT. REPORTER STATED THE CARTRIDGE AND INJECTOR DAMAGED THE LENS. NO LOT NUMBERS WERE PROVIDED. CARTRIDGE AND INJECTOR WERE NOT RETURNED FOR EVALUATION. SEE MFR #2023826-2013-00063 FOR THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26266 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE HQL STAAR SURGICAL CO. MSI-TM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS MODEL AQ2003V - SERIAL NUMBER 4722604| CARTRIDGE MODEL AQ CARTRIDGE - LOT NUMBER UNK