BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 9586886 · Received January 14, 2020

    Report

    Report Number
    2023826-2020-00067
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    December 12, 2019
    Report Date
    December 17, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - (B)(6). B5 - PER UPDATED INFORMATION, THE PATIENT ALSO DEVELOPED ANTERIOR SUBCAPSULAR CATARACT, PUPIL BLOCK, CORNEAL DECOMPENSATION, AND UNREACTIVE (FIXED) PUPIL. TOPICAL STEROIDS AND GLAUCOMA MEDICATIONS WERE PRESCRIBED. 'DIFFERENCE IN COLOUR PERCEPTION BETWEEN EYES' WAS ALSO REPORTED. THE PATIENT IS REPORTEDLY 'STABLE AND SLOWLY IMPROVING.' THE LENS REMAINS IMPLANTED AND THE SURGEON DOES NOT PLAN TO REOPERATE. THE CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR. H6 - PATIENT CODE 3191: NO CODE AVAILABLE (PUPIL BLOCK, UNREACTIVE (FIXED) PUPIL, DIFFERENCE IN COLOUR PERCEPTION). H6 - PATIENT CODE 3191: MEDICAL INTERVENTION (TOPICAL STEROIDS, GLAUCOMA MEDICATIONS). H6 - DEVICE CODE 1494: OFF-LABEL USE (ACD < 2.8MM). H6 - METHOD CODE 4110: WORK ORDER SEARCH - NO ADDITIONAL SIMILAR COMPLAINT TYPE EVENTS WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: UNK (ESUBMITTER SOFTWARE DOES NOT ALLOW FOR A BLANK OR 'UNK' ENTRY). THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT AFTER AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO A PATIENT'S EYE. "IOP WAS 27 AFTER IMPLANTATION, BUT LATER INCREASED AND REACHED 70 MM HG. MANNITOL WAS USED MULTIPLE TIMES AND PRESSURE WENT DOWN BUT THERE IS SEVERE CORNEAL EDEMA (HAZY CORNEA)." LENS REMAINS IMPLANTED. REPORTEDLY SURGEON IS "THINKING OF EXPLANTING THE LENS." REPORTER INDICATED, "PATIENT HAS ACUTE GLAUCOMA, THE SURGEON DOES NOT KNOW THE CAUSE." 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
    50441 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other| R