BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFERENCE UNIT

    MDR report key: 4620851 · Received July 31, 2014

    Report

    Report Number
    3010300699-2014-00006
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 12, 2014
    Report Date
    July 3, 2014
    Manufacturer
    WAVELIGHT GMBH AGPS
    Product Code
    HJB
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT EXPERIENCED AN UNEXPECTED REFRACTIVE OUTCOME IN THE LEFT EYE. THE LENS WAS EXCHANGED SIX WEEKS LATER FOR THE SAME MODEL LENS, 1.5 DIOPTERS DIFFERENCE IN POWER. IN A FOLLOW UP, THE SURGEON REPORTED THAT THE SYSTEM TOOK INACCURATE CORNEAL MEASUREMENTS, WHICH CAUSED THE INCORRECT IOL POWER TO BE SELECTED INITIALLY. THE SURGEON TARGETED FOR AN OUTCOME OF -2.00 FOR MONOVISION, BUT THE PATIENT ENDED UP WITH -3.25. THE EVENT RESOLVE WITH THE IOL EXCHANGE. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449219 REFERENCE UNIT KERATOMETER, PUPILLOMETER HJB WAVELIGHT GMBH AGPS X-RUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention DISCOVISC| MONARCH D CARTRIDGE| AUTOSERT HANDPIECE| LENSX| SN60WF IOL| ZYLET 0.3-0.5%| ORA