BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 7401372 · Received April 5, 2018

    Report

    Report Number
    2023826-2018-00302
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    January 20, 2018
    Report Date
    February 6, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4) SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, SECONDARY SURGERY, LENS EXCHANGE. THIS REPORT WAS INITIALLY SUBMITTED ON 06-MAR-2018 WITH THE INCORRECT MDR NUMBER 2023382-2018-00302. THE REPORT IS BEING RESUBMITTED PER FDA REQUEST UNDER CORRECT MDR NUMBER 2023826-2018-00302. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE EVALUATION: THE PRODUCT WAS RETURNED DRY, IN A MICRO-CENTRIFUGE VIAL WITH CLEAR SURGICAL RESIDUE AND DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND THE LENS HAPTIC BENT, MISSING A PIECE OF HAPTIC AND RESIDUE ON THE LENS SURFACE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM VTICMO13.2, -17.0/+1.0/109 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS REMOVED ON (B)(6) 2018 DUE TO EXCESSIVE VAULTING SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243920 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention