BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1943515 · Received December 2, 2010

    Report

    Report Number
    1119421-2010-01331
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 2, 2010
    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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. PHOTOS WERE REC'D FROM THE RPTR AND WERE REVIEWED BY COMPANY REPS, WHO CONCLUDED THAT THE SMALL OPACIFICATIONS IN THE LENS MATERIAL ARE GLISTENINGS. GLISTENINGS ARE VERY COMMON AND ARE MICROVACUOLES THAT OCCUR DUE TO THE MIGRATION OF AQUEOUS INTO THE LENS MATRIX. GLISTENINGS ALSO OCCUR WITH ALL INTRAOCULAR LENS MATERIALS TO LESSER AND GREATER DEGREES AND THERE ARE A NUMBER OF STUDIES THAT HAVE SHOWN GLISTENINGS DO NOT HAVE A NEGATIVE EFFECT ON VISUAL ACUITY. THE SURGEON HAS BEEN INFORMED OF THIS CONCLUSION. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT HAS "SOME DIFFICULTY DRIVING AT NIGHT." THE NURSE ALSO REPORTED THAT UPON "CHECKING THE PT", THE SURGEON OBSERVED "MULTIPLE SMALL OPACIFICATIONS IN THE LENS MATERIAL" (GLISTENINGS). ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other