BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3914502 · Received July 3, 2014

    Report

    Report Number
    2023826-2014-00517
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 15, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT; NO KNOWN DEVICE PROBLEM. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND OPTIC IS CUT IN HALF. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON PRODUCT. CONCLUSIONS - (NO DEVICE FAILURE): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, IT HAS BEEN DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO PHYSICIAN'S PREFERENCE. THE SURGEON CHANGED HIS MIND AND DECIDED TO IMPLANT A DIFFERENT DIOPTER SIZE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ5010V THREE PIECE SILICONE LENS INTO THE PATIENT'S EYE. AFTER INSERTION, THE SURGEON DECIDED TO REMOVE THE LENS AND TO IMPLANT A DIFFERENT DIOPTER SIZE (-4.0D). THE SURGEON CUT THE LENS TO REMOVE FROM EYE. THERE WAS NO PATIENT INJURY. NO PROBLEM WITH LENS. PHYSICIAN'S PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389802 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ5010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR