BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2947247 · Received January 30, 2013

    Report

    Report Number
    1119421-2013-00071
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    December 31, 2012
    Manufacturer
    ALCON RESEARCH. LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. DUBEY R, GRIGG J (2012) IMPROVED REFRACTIVE OUTCOME FOR CILIARY SULCUS- IMPLANTED INTRAOCULAR LENSES. OPHTHALMOLOGY 2012; 119:261-265. PATIENT CODE(S): (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE AUTHORS PRESENTED THE RESULTS OF A RETROSPECTIVE STUDY TO INVESTIGATE THE IDEAL CORRECTION OF INTRAOCULAR LENS (IOL) POWER FOR SULCUS IMPLANTATION. THE AUTHORS REVIEWED THE RECORDS OF 679 PATIENTS UNDERGOING CATARACT SURGERY FROM JUNE 2007 TO JUNE 2008. POSTERIOR CAPSULE TEARS REQUIRING IMPLANTATION OF THE IOL IN THE CILIARY SULCUS OCCURRED IN 36 EYES. WHEN COMPARING EYE IN WHICH THE POWER WAS REDUCED BY 0.5 DIOPTERS WITH THOSE IN WHICH THE REDUCTION WAS 1.0 DIOPTERS, THOSE WITH A POWER REDUCTION OF 11.0 DIOPTERS HAD SIGNIFICANTLY LESS UNEXPECTED ERROR (0.49 VS. 1.01 SE). THE AUTHORS REPORTED THAT AFTER STRATIFYING EYES BY AXIAL LENGTH (AL), THEY FOUND HIGHER UNEXPECTED REFRACTIVE ERROR IN SHORT EYES (<22 MM AL). LIKEWISE, EYES WITH A PREDICTED IOP POWER >25 DIOPTERS HAD A GREATER POSTOPERATIVE REFRACTIVE ERROR. THE MEAN DIFFERENCE IN SPHERICAL EQUIVALENT (SE) WAS HIGHER IN THE >25 DIOPTER PLANNED IOL POWER GROUP (-1.41 DIOPTER SE) THAN IN THE <25 DIOPTER PLANNED IOP POWER GROUP (-0-67). THE AUTHORS FOUND THAT THE IOP POWER SHOULD BE ADJUSTED ACCORDING TO THE MEASURED AL AND PREDICTED IOP POWER. FOR PATIENT WITH A PREDICTED IOP POWER FROM 18 TO 25 DIOPTERS, POWER SHOULD BE REDUCED BY AT LEAST ONE DIOPTER; FOR LENSES >25 DIOPTERS, POWER SHOULD BE REDUCED BY 1.5 TO 2.0 DIOPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41516 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD./HUNTINGTON MA60AC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other