BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 11616998 · Received April 5, 2021

    Report

    Report Number
    2023826-2021-00922
    Event Type
    Injury
    Date Received
    April 5, 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 - 386UM, ANGLE:20 DEGREES. THE PATIENT AND DOCTOR ARE HAPPY WITH THE RESULTS. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -16.50/+3.5/089 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD), 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
    514222 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