BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3164187 · Received June 7, 2013

    Report

    Report Number
    1119421-2013-00619
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ALCON RESEARCH, LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE RECEIVED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OF ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. CHANG A, BEHNDIG A, RONBECK M, KUGELBERG M. COMPARISON OF POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS WITH 2 HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES: 5- TO 7-YEAR F/U. J CATARACT REFRACT SURG 2013; 39:694-698. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, THE AUTHORS COMPARED THE DEVELOPMENT OF POSTERIOR CAPSULE OPACIFICATION (PCO) AND GLISTENINGS FIVE TO SEVEN YEARS FOLLOWING CATARACT SURGERY AND IMPLANTATION OF AN INTRAOCULAR LENS (IOL). THE SUBJECTS WERE DIVIDED INTO TWO STUDY GROUPS, ONE GROUP RECEIVING A ONE-PIECE IOL AND THE OTHER GROUP A THREE-PIECE IOL. BOTH STUDY LENSES HAD A POSTERIOR SQUARE-EDGED DESIGN AND WERE MADE FROM THE SAME HYDROPHOBIC ACRYLIC MATERIAL. THE STUDY ENROLLED EIGHTY PTS TOTAL, DIVIDED EQUALLY BETWEEN THE TWO IOL GROUPS. THE STUDY WAS COMPRISED OF PTS WHO HAD PHACOEMULSIFICATION CATARACT SURGERY WITHOUT INTRAOPERATIVE COMPLICATIONS FROM MAY 2003 TO APRIL 2005. ELEVEN OF THE EIGHTY PTS WERE LOST TO F/U FOR VARYING REASONS OVER THE COURSE OF THE STUDY. THE AUTHORS FOUND NO DIFFERENCE IN THE RATE OF PCO DEVELOPMENT BETWEEN THE TWO ACRYLIC HYDROPHOBIC LENS GROUPS. THE STUDY DID FIND A HIGHER RATE OF YAG CAPSULOTOMY PROCEDURES PERFORMED (16%) AT FIVE TO SEVEN YEARS POSTOPERATIVELY. THE AUTHORS RECOGNIZED THAT SEVERAL STUDIES SUGGEST THAT IN ADDITION TO THE SURGICAL TECHNIQUE, IOL MATERIAL AND DESIGN ARE IMPORTANT FACTORS IN THE DEVELOPMENT OF PCO AT DIFFERENT RATES DURING THE FIRST THREE YEARS POSTOPERATIVELY. HOWEVER, AFTER FIVE TO SEVEN YEARS, THE INITIALLY LOW PCO RATES ASSOCIATED WITH HYDROPHOBIC IOLS CAUGHT UP WITH THE PCO RATES ASSOCIATED WITH OTHER IOL MATERIALS. THE INCIDENCE OF PCO INCREASES IN ACRYLIC HYDROPHOBIC IOLS AFTER THREE YEARS AND ONE STUDY FOUND AN EVEN HIGHER PCO FREQUENCY WITH ACRYLIC HYDROPHOBIC IOLS THAN WITH SILICONE IOLS AFTER FIVE TO SEVEN YEARS. THE AUTHORS THOUGHT THIS MIGHT EXPLAIN THE HIGHER YAG CAPSULOTOMY RATE REPORTED IN THIS STUDY. IN SUMMARY, THE AUTHORS FOUND THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS FOR DEVELOPMENT OF PCO. THE GROUP WITH THE 1-PIECE LENSES DEVELOPMENT SIGNIFICANTLY MORE GLISTENINGS THAN THE 3-PIECE IOL GROUP, HOWEVER, THE GLISTENINGS DID NOT SEEM TO AFFECT VISUAL ACUITY OR CONTRAST SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253777 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SA60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1