BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 11648783 · Received April 12, 2021

    Report

    Report Number
    2023826-2021-00923
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 12, 2021
    Report Date
    March 16, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5: THE LENS WAS EXPLANTED AND EXCHANGED ON (B)(6) 2021. POST-OP VISUAL ACUITY WAS 20/30 UVA; 20/25 CVA. PIO: 18MMHG WITH NO ANTI GLAUCOMA TREATMENT. SLIT LAMP: NO INFLAMMATORY FINDINGS. VAULT 439UM; ANGLE 21 DEGREES. THE PATIENT AND THE DOCTOR ARE HAPPY WITH THE RESULTS. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 1

    WEIGHT: UNK. ETHNICITY: UNK. RACE: UNK EXPLANT DATE: UNK. REPORT SOURCE: THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). CLAIM # (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -16.00/+3.5/094 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2021. THE LENS WAS REPORTED AS EXCESSIVE VAULTING, ELEVATED INTRAOCULAR PRESSURE (IOP), AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. TOPICAL ANTIHYPERTENSIVE TREATMENT (KRYTANTEK) WAS ADMINISTERED. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544506 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention CARTRIDGE MODEL SFC-45 - LOT # 1493059| FOAM TIP PLUNGER MODEL FTP - LOT # 1495759| INJECTOR MODEL MSI-TF - LOT # UNK| CARTRIDGE MODEL SFC-45 - LOT # 1493059| FOAM TIP PLUNGER MODEL FTP - LOT # 1495759| INJECTOR MODEL MSI-TF - LOT # UNK