BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 2190826 · Received July 8, 2011

    Report

    Report Number
    1119421-2011-00854
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    March 21, 2011
    Report Date
    June 8, 2011
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH A MISALIGNED INTRAOCULAR LENS (IOL) FOLLOWING IMPLANT SURGERY. THE SURGEON STATED IT WAS DUE TO THE PT'S "BAD" PSEUDOEXFOLIATION AND WEAK ZONULES. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT AND BELIEVES THAT THERE WAS EXCESS POSTOPERATIVE CAPSULAR CONTRACTION FACILITATED BY THE ZONULAR LAXITY SECONDARY TO THE PT'S PSEUDOEXFOLIATION SYNDROME. THE SURGEON REPORTED AN ATTEMPT WAS MADE TO ROTATE THE IOL DURING A SECONDARY PROCEDURE, BUT IT WAS UNSUCCESSFUL DUE TO SEVERE ZONULAR LAXITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60T9 11056748

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PROVISC| HANDPIECE (UNSPECIFIED)| MAXIDEX| MONARCH CARTRIDGE| VOLTAREN