BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3001569 · Received March 11, 2013

    Report

    Report Number
    1119421-2013-00256
    Event Type
    Injury
    Date Received
    March 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IN AN ARTICLE ON SOCIAL MEDIA, THE AUTHOR DISCUSSES VARIOUS REASONS FOR PT DISSATISFACTION FOLLOWING IMPLANTATION OF PREMIUM INTRAOCULAR LENSES (IOLS). IT WAS THE OPINION OF THIS AUTHOR THAT REFRACTIVE ERROR WAS THE MOST COMMON CAUSE OF PT DISSATISFACTION WITH PREMIUM IOLS. HE NOTED THE MULTIFOCAL IOL IMAGE QUALITY WAS MORE SENSITIVE TO DEFOCUS AND ASTIGMATIC ERRORS. THE AUTHOR NOTED THAT INVESTIGATORS IN (B)(6) HAD OBSERVED THAT FOLLOWING THE IMPLANT OF THIS MODEL IOL, MOST PTS COULD TOLERATE UP TO 1.00 DIOPTERS OF ASTIGMATISM. ANOTHER STUDY REPORTED THAT PTS TOLERATED UP TO 1.00 DIOPTERS OF ASTIGMATISM AND 0.75 MM OF DECENTRATION OF THE LENS. THE AUTHORS NOTED THAT NEITHER OF THESE STUDIES LOOKED AT HIGHER ORDER ABERRATIONS THAT CAN PLAY A ROLE IN PT SATISFACTION. IN THIS DISCUSSION ON OPTIMIZING OUTCOME OF PREMIUM IOLS, THE AUTHOR NOTED A STUDY CONDUCTED AT (B)(6). THIS STUDY REPORTED THE RESULTS OF TREATING PTS WITH LIMBAL RELAXING INCISIONS (LRI) VERSUS A COMBINATION OF LIMBAL RELAXING INCISIONS AND LASIK FOR PTS WITH MIXED ASTIGMATISM. THIS STUDY REPORTED THAT THE PTS TREATED WITH COMBINATION THERAPY HAD A GREATER PERCENTAGE OF 20/25 UCVA EYES ((B)(4)) COMPARED TO THE LRI ONLY GROUP ((B)(4)). THE STUDY NOTED THAT LRIS ARE SIMPLE TO DO EITHER INTRAOPERATIVELY OR POSTOPERATIVELY. THIS WAS RECOMMENDED FOR PTS WITH 1.50 DIOPTERS OR LESS OF MIXED ASTIGMATISM. THIS REPORT CAPTURES ALL EVENTS RELATED IN THIS ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101740 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention