BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 13286583 · Received January 18, 2022

    Report

    Report Number
    2023826-2022-00174
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    December 22, 2021
    Report Date
    December 22, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542108645
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    H3: DEVICE EVALUATION: THE LENS WAS RETURNED IN LIQUID IN A VIAL. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS. DIMENSIONAL INSPECTION FOUND THE LENS TO BE WITHIN SPECIFICATIONS. CLAIM#: (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -7.00/+3.50/100 (SPHERE/ CYLINDER/ AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE PATIENT EXPERIENCED EXCESSIVE VAULTING; SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES; ANGLE CLOSURE WITH ELEVATED IOP; MEDICATION WAS PRESCRIBED (DIAMOX); ON (B)(6) 2021 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS BUT IT WAS LATER REPORTED THAT THE ISSUE WAS NOT RESOLVED AND THE PATIENT HAS PUPIL BLOCK/FIXED PUPIL; PRESSURE SPIKES AND PRK SURGERY WAS PERFORMED DUE TO THE VISION. THE CAUSE OF THE EVENT WAS REPORTED AS "OTHER UNEXPECTED SHORT CILIARY SULCUS SPACE". SEE MDR # 2023826-2022-00176 FOR REPLACEMENT LENS CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052418 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY TMICL13.2 N/A 00841542108645

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention