BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 12807798 · Received November 12, 2021

    Report

    Report Number
    2023826-2021-04263
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    August 17, 2021
    Report Date
    October 19, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    H3: DEVICE EVALUATION - LENS WAS RETURNED IN MICROCENTRIFUGE VIAL WITH MOISTURE. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE LENS. DIMENSIONAL INSPECTION FOUND THE LENS TO BE WITHIN SPECIFICATION. FUNCTIONAL INSPECTION FOUND THAT THE RETURNED LENS DID NOT MEET ORIGINAL VALUES MEASURED AT THE TIME OF MANUFACTURING. H6: DEVICE HISTORY RECORD (OHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE; HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PROCESS PARAMETERS; AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -9.5/+1.5/174 (SPHERE/ CYLINDER/ AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXCHANGED WITH A SAME LENGTH DIFFERENT MODEL LENS DUE TO REFRACTIVE SURPRISE. THE PROBLEM IS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700942 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention