BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2873114 · Received December 13, 2012

    Report

    Report Number
    2023826-2012-00983
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS SPLIT IN HALF AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ2015A SILICONE THREE PIECE LENS IN THE EYE AND NOTED A CRACK ON THE OPTIC. THE LENS WA CUT OUT OF THE EYE WITHOUT ANY COMPLICATIONS AND NO SUTURES REQUIRED. THE REPORTER INDICATED THE INCIDENT WAS A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2015A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 AQ CARTRIDGE-FP MODEL, LOT NUMBER UNKNOWN| INJECTOR MODEL MSI-TM, LOT NUMBER UNKNOWN