BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2063756 · Received April 14, 2011

    Report

    Report Number
    1119421-2011-00408
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS RETURNED FOR ANALYSIS, AND THE REPORTED COMPLAINT COULD NOT BE VERIFIED. THE PRODUCT WAS DAMAGED AND THIS DAMAGE WAS NOT MENTIONED BY THE CUSTOMER. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. UPON RETURN, THE LENS WAS OBSERVED TO BE IMPROPERLY RE-CASED BY THE CUSTOMER THAT RESULTED IN OPTIC DAMAGE. ROOT CAUSE: WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MFG RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION, THE DAMAGE IS POTENTIALLY RELATED TO CUSTOMER HANDLING. INFO PROVIDED INDICATED A FAILURE TO FOLLOW THE DIRECTIONS FOR USE, UNAPPROVED VISCOELASTIC USED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY TO THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 03/17/2011 BY FAX AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECH REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO "DIOPTER POWER FAILURE". THE PT HAD A HISTORY OF DRY EYES AND A PRIOR LASIK PROCEDURE (PRE-EXISTING). POSTERIOR CAPSULE OPACIFICATION WAS NOTED. IN A F/U, THE SURGEON REPORTED THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE EVENT RESOLVED FOLLOWING THE EXCHANGE PROCEDURE. THE SURGEON REPORTED THE USE OF AN UNAPPROVED VISCOELASTIC DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12001599

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention NEVANAC| PREDFORTE| HEALON| ARTIFICIAL TEARS| ZYMAXID