BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 17871756 · Received October 4, 2023

    Report

    Report Number
    3012236936-2023-02466
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Report Date
    October 4, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D4 - SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION- SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SURGEON AT THE EUROPEAN SOCIETY OF CATARACT AND REFRACTIVE SURGEONS (ESCRS) CONGRESS USES COMPETITOR LENSES FOR SULCUS PLACEMENT IN PLACE OF OUR SUGGESTED STAND ALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL). HE SAID THE OPTIC OF THIS MODEL ALWAYS STICKS TOGETHER AND HE NEEDS TO INTERVENE WITH TWO (02) INSTRUMENTS TO SEPARATE THE HAPTIC. WE LEARNED THROUGH FOLLOW UP THAT THE ISSUE WAS THE OPTIC STUCK TOGETHER, NOT THE HAPTICS AS THEY ARE A DIFFERENT MATERIAL, MADE OF POLYMETHYL METHACRYLATE (PMMA). THE SURGEON OBSERVED THE ISSUE SEVERAL TIMES DURING SURGERY. IN RELATION TO THE PAST OCCURRENCES OF THIS ISSUE WE WERE TOLD THAT MOST WERE REPORTED ALREADY. THIS ISSUE CAUSED DELAYS BECAUSE THE SURGEON HAD TO USE TWO (02) INSTRUMENTS TO UNSTICK THE OPTIC. WE WERE ADVISED THAT THIS WAS A GENERAL COMPLAINT WITH RESPECT TO THIS PARTICULAR MODEL OF IOL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91462 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown