BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2061029 · Received April 8, 2011

    Report

    Report Number
    1119421-2011-00388
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED. 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 BY THE APPROPRIATE RESPONSIBLE MGMT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 03/18/2011 AND 03/25/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/28/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH ONE DIOPTER OF REMAINING CYLINDER FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATED THAT THE LENS WAS IMPLANTED BY ANOTHER SURGEON. IN A F/U, IT WAS INDICATED THAT BOTH THE IMPLANTING SURGEON AND CURRENT SURGEON ARE IN THE SAME PRACTICE. THE IMPLANTING SURGEON REPORTED THAT THE EVENT CONTINUES BUT IS EXPECTED TO RESOLVE. SHE ALSO NOTED POSTERIOR CAPSULE OPACIFICATION (PCO) APPROXIMATELY THREE MONTHS AFTER IMPLANTATION. IT WAS ALSO INDICATED THAT AN UNAPPROVED VISCOELASTIC WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 11070911

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other OMNIPRED| MONARCH DELIVERY SYSTEM| NEVENAC| DISCOVISC| VIGAMOX