BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 8678984 · Received June 7, 2019

    Report

    Report Number
    2023826-2019-01025
    Event Type
    Injury
    Date Received
    June 7, 2019
    Report Date
    May 13, 2019
    Manufacturer
    N/A
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED TO: AN ARTICLE WAS PUBLISHED IN THE JOURNAL OF ADVANCES IN MEDICINE AND MEDICAL RESEARCH IN MARCH 2019 TITLED, 'TORIC AND PHAKIC IOLS FOR THE TREATMENT OF ASTIGMATISM AND OR HIGH MYOPIA: OUR EXPERIENCE AT PRINCE HASHEM HOSPITAL ZARQA.' THE ARTICLE STATES THAT 3 PATIENTS WHO UNDERWENT TORIC INTRA-OCULAR LENS IMPLANTATION HAD LENS ROTATION A FEW DAYS AFTER SURGERY THAT RESULTED IN A DECREASE IN IN THEIR VISUAL ACUITY AND THAT WAS OVERCOME BY REALIGNMENT OF THEIR IOL INTRAOPERATIVELY. IT WAS DETERMINED THAT THE IOLS USED WERE ACRI LISA TORIC (CARL ZEISS MEDITEC) INTRAOCULAR LENSES AND ARE THEREFORE NOT MANUFACTURED BY STAAR. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT MANUFACTURED BUT NOT SOLD IN THE U.S. CLAIM# (B)(4).

    Description of Event or Problem · 1

    AN ARTICLE WAS PUBLISHED IN THE JOURNAL OF ADVANCES IN MEDICINE AND MEDICAL RESEARCH IN MARCH 2019 TITLED, 'TORIC AND PHAKIC IOLS FOR THE TREATMENT OF ASTIGMATISM AND/OR HIGH MYOPIA: OUR EXPERIENCE AT PRINCE HASHEM HOSPITAL ZARQA.' THE ARTICLE STATES THAT 3 PATIENTS WHO UNDERWENT TORIC INTRA-OCULAR LENS IMPLANTATION HAD LENS ROTATION A FEW DAYS AFTER SURGERY THAT RESULTED IN A DECREASE IN THEIR VISUAL ACUITY AND THAT WAS OVERCOME BY REALIGNMENT OF THEIR IOL INTRAOPERATIVELY. ALL PATIENTS HAD SATISFACTORY IMPROVEMENTS IN THEIR VISUAL ACUITIES. THEY WERE FOLLOWED FOR UP TO 3 MONTHS WITH NO CHANGE TO THEIR BCVA OR THEIR LENS STATUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471593 N/A N/A QCB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention