BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2512290 · Received March 28, 2012

    Report

    Report Number
    1119421-2012-00425
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    January 1, 2011
    Report Date
    February 27, 2012
    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
    NOT APPLICABLE

    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. THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THIS LOT. ADDITIONAL INFO WAS REQUESTED BY PHONE, FAX AND MAIL ON 02/27/2012, 02/29/2012, 03/06/2012 AND 03/14/2012. A COMPLETED QUESTIONNAIRE WAS RECEIVED FROM THE CONSUMER'S CURRENT SURGEON ON 03/06/2012 AND A PARTIALLY COMPLETED QUESTIONNAIRE WAS RECEIVED FROM THE IMPLANTING SURGEON ON 03/06/2012. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOUR YEARS FOLLOWING HIS INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS CURRENT SURGEON, (NOT THE IMPLANTING SURGEON), INDICATED THAT HIS IOL WAS DECENTERED AND HIS INTRAOCULAR PRESSURE (IOP) HAS INCREASED. ADDITIONAL INFO WAS RECEIVED FROM THE CONSUMER'S CURRENT SURGEON WHO CONFIRMED THE IOL WAS IMPLANTED IN THE SULCUS AND HAD DECENTERED TEMPORALLY WITH TRANSILLUMINATION DEFECTS AND INCREASED IOP. SHE ALSO STATED THAT THERE WAS NO POSTERIOR CAPSULAR OPACIFICATION (PCO) OBSERVED AND THAT THE CAPSULE WAS OPEN, PRESUMABLY FROM TIME OF SURGERY. ADDITIONAL INFO WAS RECEIVED FROM THE IMPLANTING SURGEON STATING THAT HE WAS UNSURE IF THE IOL WAS IN THE CAPSULAR BAG AND THAT NO PCO HAD BEEN OBSERVED. HE ALSO STATED THE CONSUMER'S LAST VISIT WITH HIM WAS ONE AND A HALF YEARS AGO. THE SURGEON INDICATED THE USE OF AN UNAPPROVED VISCOELASTIC DURING THE SURGICAL PROCEDURE. IN AN ADDITIONAL FOLLOW-UP WITH THE CONSUMER'S CURRENT SURGEON, SHE INDICATED THAT THE IOL HAD BEEN EXCHANGED FOR DIFFERENT MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH. LTD./HUNTINGTON SN6AD3 10736823

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention AMVISC