BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 5394034 · Received January 27, 2016

    Report

    Report Number
    2023826-2016-00101
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    December 16, 2015
    Report Date
    December 28, 2015
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIOPTER: +05.00 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4).

    Additional Manufacturer Narrative · 1

    PER MEDICAL REVIEW: OD: REPORTEDLY, HAPTIC OF THE 3-PIECE SILICONE IOL WAS TORN OFF DURING INSERTION REQUIRING INTRAOPERATIVE LENS REMOVAL/EXCHANGE. NO REPORTED INCISION ENLARGEMENT OR ANY OTHER TISSUE DAMAGE. BACKUP LENS OF SAME MODEL WAS SUCCESSFULLY IMPLANTED. ACCORDING TO THE REPORT, DATED ON (B)(6) 2016, THE CAUSE OF THE EVENT WAS LOADING ERROR. THE REPORT, BY A SURGICAL TECHNICIAN, DATED ON (B)(6) 201616 STATED THAT THERE WAS NO PATIENT INJURY. IT SHOULD BE NOTED THAT AT THE TIME OF THE SURGERY THE PATIENT WAS (B)(6) YEARS OLD AND PER DFU INDICATIONS:" THE SILICONE 3P IOLS ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION." DEVICE HISTORY REPORT REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALS NOTHING IN THE MANUFACTURING, INSPECTION OR PACKAGING PROCESS RECORDS THAT SUGGESTS A CONTRIBUTORY FACTOR TO THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2010V +05.00 THREE PIECE SILICONE LENS. THE LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. THE HAPTIC BROKE ON INSERTION INTO THE EYE. LENS WAS REMOVED AND ANOTHER SAME MODEL LENS WAS IMPLANTED. THERE WAS NO INJURY TO THE PATIENT. CAUSE OF THIS INCIDENT WAS LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50868 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR CARTRIDGE MODEL AND LOT NUMBER - UNK