BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPLANTABLE COLLAMER LENS

    MDR report key: 12021862 · Received June 17, 2021

    Report

    Report Number
    2023826-2021-02006
    Event Type
    Death
    Date Received
    June 17, 2021
    Date of Event
    August 6, 2020
    Report Date
    May 28, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THIS IS A CASE OF FOREIGN DEBRIS ON THE LENS THAT CAUSED THE EXCHANGE. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    H3: DEVICE EVALUATION: THE LENS WAS RETURNED IN LIQUID IN A MICRO-CENTRIFUGE VIAL. THERE WAS RESIDUE/DEBRIS ON THE PRODUCT. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE LENS. AND THERE WAS RESIDUE AND DEBRIS ON THE LENS SURFACE. RED PARTICULATES WERE NOTED, ON LENS OPTIC. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS; -9.5/+6.0/107. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    B5-FINAL BCVA 0.85, UCVA 0.7. H6-METHOD CODE 3331: DEVICE HISTORY RECORD (DHR) 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).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -9.5/+6.0/108 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2020. ON (B)(6) 2020 THE LENS WAS EXCHANGED WITH AN ALTERNATE LENS DUE TO LENS OPACITY-CORTICAL. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN. THE SURGEON STATES THAT THE LENS HAS A DEPOSIT ON ITS SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911658 IMPLANTABLE COLLAMER LENS PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention UNK.