BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3131113 · Received May 23, 2013

    Report

    Report Number
    1119421-2013-00560
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 24, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE LENS WAS RETURNED MISPOSITIONED INSIDE A NON-ALCON LENS CASE. SOLUTION, BENT HAPTIC DAMAGE AND OPTIC DAMAGE WERE OBSERVED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE OPTICAL RESOLUTION IS ACCEPTABLE; LENS MEETS SPECIFICATION FOR FOCAL LENGTH EQUALING A 14.5 DIOPTER. AN UNAPPROVED VISCOELASTIC WAS REPORTED TO HAVE BEEN USED. THIS IS AN UNAPPROVED COMBINATION OF PRODUCTS. NOT ENOUGH INFO WAS PROVIDED TO CONDUCT A REVIEW OF THE CARTRIDGE LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE COMPLAINT OF MECHANICAL FAILURE AND BLURRY VISION. THE SPECIFIC 'MECHANICAL FAILURE' WAS NOT SPECIFIED. LENS DAMAGE WAS OBSERVED. EXACT FOCAL LENGTH/RESOLUTION MEASUREMENTS COULD NOT BE OBTAINED DUE TO THE OPTIC DAMAGE. HOWEVER, THE LENS IS WITHIN THE 14.5 DIOPTER RANGE. THE LENS DAMAGE MOST LIKELY IS RELATED TO A FAILURE TO FOLLOW THE DFU. THE FILE INDICATES THE USE OF AN UNAPPROVED VISCOELASTIC, AND AN UNAPPROVED HANDPIECE USED WITH THE CARTRIDGE/LENS COMBINATION. DUE TO VARYING VISCOSITY, THE USE OF UNAPPROVED VISCOELASTICS MAY RESULT IN LENS DELIVERY DIFFICULTIES OR PRODUCT DAMAGE. NO OTHER COMPLAINTS REPORTED IN THIS LOT. ADD'L INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY THE LENS WAS EXCHANGED DUE TO MECHANICAL FAILURE AND THE PATIENT'S REPORT OF BLURRY VISION. POSTERIOR CAPSULAR OPACIFICATION WAS OBSERVED PRIOR TO THE EXCHANGE PROCEDURE. ADD'L INFO RECEIVED FROM THE SURGEON REPORTS THE PATIENT'S BLURRY VISION CONTINUES AND IS NOT EXPECTED TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229593 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON SN6AD1 1261073

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention AMVISC PLUS| MONARCH II HANDPIECE| MONARCH D CARTRIDGE