BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1912270 · Received November 23, 2010

    Report

    Report Number
    2023826-2010-01169
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVAL. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND HAPTIC TORN OFF AND MISSING. LENS WAS RETURNED IN LENS CASE. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. EVAL CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED IN JUNE 2005 (WHICH WAS SUBSEQUENTLY CLOSED). THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MFG 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 EVAL 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 INSERTED AN AQ2015A 22.5 DIOPTER LENS. THE LENS TORE ON INSERTION INTO THE EYE. LENS WAS REMOVED WITH NO PT INJURY. NO WIDENED INCISION AND NO SUTURE. BACKUP LENS WAS IMPLANTED USING A NEW INJECTOR. THE REPORTER STATED THE LENS WAS DAMAGED BY THE INJECTOR. NO LOT NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. MSI-PM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR LENS: MODEL AQ2015A -(B)(4)| VISCOELASTIC: -STAARVISC II -LOT # UNK| CARTRIDGE: MODEL AQ CARTRIDGE -LOT # UNK