BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2673074 · Received July 26, 2012

    Report

    Report Number
    1119421-2012-00926
    Event Type
    Injury
    Date Received
    July 26, 2012
    Date of Event
    January 1, 2011
    Report Date
    June 26, 2012
    Manufacturer
    ALCON RESEARCH LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFO WAS PROVIDED FROM THE REPORTER TO PROPERLY COMPLETE AN INVESTIGATION. NO ROOT CAUSE COULD BE DETERMINED. MIYATA, K., HONBO, M., OTANI, S., NEJIMA, R., MINAMI, K. (2012). EFFECT ON VISUAL ACUITY OF INCREASED SURFACE LIGHT SCATTERING IN INTRAOCULAR LENSES. JOURNAL OF CATARACT REFRACTIVE SURGERY, 38, 221-226. (B)(4).

    Description of Event or Problem · 1

    A LITERATURE ARTICLE REPORTED AN INCREASE IN SURFACE LIGHT SCATTERING FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. LIGHT SCATTERINGS WERE MEASURED ONE YEAR POSTOPERATIVELY OR GREATER AND THE CORRECTED DISTANCE VISUAL ACUITY (CDVA) WAS COMPARED TO THE CDVA ONE MONTH AFTER IOL IMPLANTATION. THE CHANGES IN CDVA OVERTIME WERE COMPARED TO THE INCREASE IN SURFACE LIGHT SCATTERING. THE ARTICLE CONCLUDED THAT LIGHT SCATTERING INCREASED CONTINUALLY OVER THE YEARS AND THE INCREASE WAS GREATER ON THE POSTERIOR SURFACE OF THE LENS. THE INCREASE IN THE SURFACE LIGHT SCATTERING DID NOT CAUSE A SIGNIFICANT CHANGE IN THE PT¿S VISUAL ACUITY; HOWEVER, THERE WERE MORE CASES WITH DECREASED CDVA WHEN THE SURFACE LIGHT SCATTERING EXCEEDED 50 COMPUTER COMPATIBLE TAPE STEPS. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD. / HUNTINGTON SA60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other