BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2479052 · Received March 2, 2012

    Report

    Report Number
    9612169-2012-00010
    Event Type
    Injury
    Date Received
    March 2, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 3, 2012
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND DAMAGE WAS OBSERVED TO THE LENS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS: LENS RETURNED POSITIONED INCORRECTLY. SOLUTION WAS DRIED ON THE LENS. BOTH HAPTICS WERE BROKEN/TORN AT THE GUSSET AREAS. ONE HAPTIC WAS NOT RETURNED AND THE OTHER HAPTIC WAS RETURNED STUCK INSIDE THE CARTRIDGE. THE OPTIC WAS SCRATCHED/MARKED AND ALSO TORN/SPLIT/CRACKED, POSSIBLY CUT. THE REPORTER INDICATED THE USE OF AN UNAPPROVED VISCOELASTIC. THERE HAVE BEEN NO OTHER COMPANIES REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT TWICE, DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, ONE OF THE IOL HAPTICS WAS "NOT PROPER" AND TORE OFF. THE LENSES WERE REMOVED AND REPLACED DURING THE SAME SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A THIRD IOL. IN A FOLLOW UP, THE SURGEON REPORTED THAT THE PT'S RECOVERY WAS PROLONGED DUE TO CORNEAL EDEMA AND DESCEMET'S WRINKLES. HE ALSO STATED THAT IN BOTH INSTANCES, THE REAR HAPTIC OF THE LENS WAS TORN OFF IN THE CARTRIDGE. THE INFORMATION PROVIDED INDICATED THE USE OF AN UNAPPROVED VISCOELASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST OF TWO LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21040833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MONARCH "D" CARTRIDGE| PEHA VISCO (2.4%)