BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2435616 · Received February 1, 2012

    Report

    Report Number
    2023826-2012-00088
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 5, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS FILE INDICATES THAT THE ICL WAS EXCHANGED DUE TO HYPEROPIA POST-ICL IMPLANTATION. TARGET REFRACTION SEQ = +0.06 AND POST-OP REFRACTION SEQ = +1.50. THE VAULT WAS 150% WHICH IS IDEAL WITH NO OTHER SYMPTOMS, BUT SINCE AN EXCHANGE FOR POWER WAS BEING PERFORMED, THE SURGEON OPTED TO EXCHANGE THE SIZE AS WELL. ICL IMPLANTED WAS -12.5D AND EXCHANGED FOR -11.0D. THIS INDICATES THAT THE SURGEON BELIEVES THAT THE PRE-OP REFRACTION WAS INCORRECT OR SHE WOULD NOT HAVE CHANGED THE POWER TO BE IMPLANTED. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS AN UNSTABLE OR INCORRECT PRE-OP REFRACTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE VISUAL INSPECTION OF THE LENS SHOWED THE LENS WAS RETURNED IN LIQUID AND THERE WAS NO VISIBLE DAMAGE OBSERVED. A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON INSERTED A MICL 13.2 IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 AND THE LENS WAS REMOVED ON (B)(6) 2012 DUE TO EXCESSIVE VAULT. THERE WAS A HYPEROPIC SURPRISE WITH THIS LENS. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH FORM WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY MICL13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention