BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3122024 · Received May 16, 2013

    Report

    Report Number
    1119421-2013-00540
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE 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. THE FILE INDICATED THE USE OF A MONARCH CARTRIDGE (MODEL NOT IDENTIFIED). THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED FOR THE MONARCH LOT BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. NO FURTHER INFORMATION IS EXPECTED FOR THIS FILE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT OVER THE PAST YEAR, HE BEGAN TO NOTICE MORE POOR REFRACTIVE OUTCOMES FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES. THE SURGEON IS UNSURE WHY HE IS HAVING THE HYPEROPIC RESULTS. HE HAS LOOKED AT HOW HIS CALCULATIONS ARE BEING DONE, WHICH FORMULAS ARE BEING USED AND HAS BEEN UNABLE TO PINPOINT A SPECIFIC REASON FOR THESE RESULTS. THE SURGEON IS UNSURE HOW MANY POOR OUTCOMES HE HAS HAD TO DATE. FOR THIS PATIENT, THE SURGEON REPORTED THIS PATIENT WAS AT +1.75 DIOPTERS AT SIX MONTHS POSTOPERATIVE. HE HAD AIMED FOR A RESULT OF -0.60 DIOPTERS. THE SURGEON REPORTED HE IS PLANNING A PIGGY BACK PROCEDURE FOR THIS PATIENT TO CORRECT THE HYPEROPIA. NO FURTHER INFORMATION IS EXPECTED FOR THIS FILE. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND IDENTIFIED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217034 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other