BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFERENCE UNIT

    MDR report key: 4605195 · Received March 13, 2015

    Report

    Report Number
    3010300699-2015-00001
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    December 16, 2014
    Report Date
    February 11, 2015
    Manufacturer
    WAVELIGHT GMBH AGPS
    Product Code
    HJB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE IMPLANTED A TORIC INTRAOCULAR LENS (IOL), AS SUGGESTED BY THE CALCULATIONS OF THE SYS'S SOFTWARE. THE PT PRESENTED WITH ADD'L ASTIGMATISM AND BLURRED VISION, POSTOPERATIVELY. THE SURGEON EXCHANGED THE TORIC IOL FOR A SINGLE VISION IOL OF THE SAME POWER, AND THE EVENT RESOLVED. NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172805 REFERENCE UNIT KERATOMETER, PUPILLOMETER HJB WAVELIGHT GMBH AGPS X-RUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention MONARCH CARTRIDGE| MONARCH HANDPIECE| PROVISC| ACRYSOF TORIC IOL (B)(4)| VISCOAT