BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 19265062 · Received May 7, 2024

    Report

    Report Number
    3012236936-2024-000126
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 7, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474502161
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED PHYSICIAN EMAIL ADDRESS: NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS WAS (IOL) WAS LOADED AND INSERTED INTO THE LEFT EYE OF THE PATIENT. BUT UPON INSERTION IT WAS NOTED THAT THE TRAILING HAPTIC WAS BENT. WHILE GETTING THE IOL INTO PLACE, AND WHILE REMOVING THE IOL, THE POSTERIOR CAPSULE WAS PUNCTURED AND A VITRECTOMY WAS REQUIRED. A BACKUP IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. TWO SUTURES WERE PERFORMED TO CLOSE THE MAIN INCISION AND THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. THE PATIENT WAS SENT TO RETINA SPECIALIST THE FOLLOWING DAY FOR EVALUATION AS THE SECOND IOL WAS NOT STABLE. THE INSERTER USED WAS AN EMERALD SERIES. BALANCED SALT SOLUTION (BSS) WAS USED AS A CARTRIDGE LUBRICANT AT ROOM TEMPERATURE. ACCOUNT STATED THAT THERE WAS A LOADING ERROR AS THE TECH DID NOT SEE THAT THE TRAILING HAPTIC WAS NOT PLACED PROPERLY BEFORE ADVANCING THE IOL. THE PATIENT WAS STABLE AND THE IOL WAS SAFELY REMOVED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770974 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474502161

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention