BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023594 · Received January 19, 2011

    Report

    Report Number
    1119421-2011-00051
    Event Type
    Other
    Date Received
    January 19, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 20, 2010
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. 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 MANAGEMENT PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT HAD A POSTOPERATIVE REFRACTION OF -0.75 WITH "NO COMPLAINTS." THE TARGET WAS PLANO. IT WAS ALSO REPORTED THAT THE PATIENT HAS A HISTORY OF A MACULAR PUCKER AND RETINAL DETACHMENT. THE PROCEDURE WAS CATARACT/SCLERAL BUCKLE SURGERY THAT WAS PERFORMED BY ANOTHER SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60BM NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other