BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 8551904 · Received April 25, 2019

    Report

    Report Number
    1119421-2019-00537
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    March 13, 2019
    Report Date
    June 25, 2019
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE CUSTOMER INDICATED THE USE OF A QUALIFIED CARTRIDGE AND HANDPIECE. CARTRIDGE 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. TWO VISCOELASTICS WERE INDICATED, ONLY ONE IS QUALIFIED FOR THIS LENS WITH THE QUALIFIED CARTRIDGE COMBINATIONS.THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT FOLLOWING BILATERAL CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, HE EXPERIENCED FLOATERS. ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT THAT HE IS ALSO EXPERIENCING GLARE AND HALOS WITH DECREASED VISION AND FLOATERS. ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT'S SURGEON THAT THE PATIENT'S CATARACT SURGERY WENT WELL WITH NO IMMEDIATE NOR POSTOPERATIVE COMPLICATIONS. THERE WAS NO PATIENT HARM. THERE ARE POSTERIOR CAPSULAR OPACITIES AT ABOUT 2+. YAG LASER HAS BEEN DISCUSSED WITH THE PATIENT. THE SURGEON FEELS IT IS TOO EARLY POSTOPERATIVELY TO RECOMMEND YAG POSTERIOR CAPSULOTOMY AT THIS TIME. THE SURGEON CANNOT FIND A DIRECT CORRELATION BETWEEN CATARACT SURGERY AND THE PATIENT'S SEVERE COMPLAINT OF HALOS AND POOR ACUITY GIVEN THE EXCEPTION OF SIDE EFFECTS FROM THE IMPLANT TECHNOLOGY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THE RIGHT EYE IS REPORTED UNDER MFG REPORT NUM 1119421-2019-00400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343355 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON SN6AD1 12522200

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other DUOVISC| MONARCH II B CARTRIDGE| MONARCH II IOL DELIVERY SYSTEM