BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR

    MDR report key: 5464951 · Received February 26, 2016

    Report

    Report Number
    2023826-2016-00212
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    January 28, 2016
    Report Date
    January 29, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K940593
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER?: NO. THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND PIECE OF HAPTIC TORN OFF AND MISSING. THE OPTIC IS TORN AT THE LOOP HAPTIC JUNCTION. THERE WAS EVIDENCE OF DRY CLEAR SURGICAL RESIDUE ON OPTIC SURFACE. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW RESULT: UPON REVIEW OF THE DEVICE HISTORY RECORD, THERE IS NOTHING IN THE MANUFACTURING, INSPECTION AND PACKAGING PROCESS RECORDS TO SUGGEST A CONTRIBUTORY FACTOR TO THE COMPLAINT. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW, DEVICE HISTORY RECORD REVIEW AND THE LENS EVALUATION, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. CLAIM # (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN AQ2010V +06.00 THREE PIECE SILICONE LENS. THE LENS TORE ON INSERTION INTO THE PATIENT'S RIGHT EYE. THE LENS WAS REMOVED AND ANOTHER LENS, SAME MODEL AND SIZE WAS IMPLANTED. THERE WAS NO PATIENT INJURY. CAUSE OF LENS TEAR WAS A FAULTY INJECTOR. THE PLUNGER TIP ON THE INJECTOR WAS BENT. NO LOT NUMBER WAS PROVIDED TO INJECTOR. SEE MFR. #2023826-2016-0000120 FOR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120643 MICROSTAAR® INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY MSI-PM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR