BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8679004 · Received June 7, 2019

    Report

    Report Number
    2023826-2019-01028
    Event Type
    Injury
    Date Received
    June 7, 2019
    Report Date
    May 13, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH - UNK. SEX - UNK. WEIGHT - UNK. ETHNICITY - UNK. RACE - UNK. DATE OF EVENT - UNK. MODEL# - UNK. IMPLANT DATE - UNK. THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4). DEVICE MANUFACTURE - DATE-UNK (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 ONE PATIENT WITH KERATOCONUS WHO HAD A VISIAN ICL IMPLANTED SHOWED PROGRESSION OF HIS KERATOCONUS DESPITE HIS CORNEA WAS CROSS-LINKED WITH THE USE OF ISOTONIC RIBOFLAVIN AND WAS OBSERVED FOR ONE YEAR BEFORE SURGERY. HE WAS OBSERVED FOR ANOTHER 6 MONTHS TO MAKE SURE HE DID NOT PROGRESS MORE BEFORE DECIDING ON EXCHANGING THE ICL IN ONE OF HIS EYES. 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
    472037 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention