BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR

    MDR report key: 7530214 · Received May 21, 2018

    Report

    Report Number
    2648035-2018-00741
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Report Date
    June 22, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN, NOT PROVIDED. SEX/GENDER: UNKNOWN, NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL #: UNKNOWN/NOT PROVIDED. CATALOG #: COMPLETE CATALOG NUMBER UNKNOWN SINCE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN SINCE SERIAL NUMBER WAS NOT PROVIDED. UDI #: UNKNOWN SINCE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, AN EXACT DATE WAS NOT PROVIDED (AROUND 10 YEARS AGO). (B)(6). MANUFACTURING DATE: UNKNOWN SINCE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED THAT THE LENS HAD NO SIGN OF CLOUDINESS OR WHITE CLOUDY SPOTS. SMALL DARK SPOTS WERE OBSERVED ON THE LENS SURFACE. THERE WAS NO EVIDENCE TO SUGGEST THAT THE RETURNED COMPLAINT LENS WAS NEGATIVELY AFFECTED BY THE MANUFACTURING PROCESS. THE LENS WAS ALSO ANALYSED USING A SCANNING ELECTRON MICROSCOPE (SEM) EQUIPPED WITH AN ENERGY DISPERSIVE X-RAY (EDX) - SEM/EDX. THE RESULTS REVEALED THAT THE INCLUSIONS (DARK SPOTS ON THE LENS) WERE POROUS STRUCTURES EMBEDDED IN THE LENS. THE ELEMENTAL COMPOSITION WAS SIMILAR TO THE BACKGROUND ACRYLIC. THIS DOES NOT MEAN THAT IT WAS ACRYLIC, MERELY A SIMILAR ORGANIC CARBON BASED COMPOUND OR MIXTURE. TRACE AMOUNTS OF SILICON (SI) WERE OBSERVED BUT THE LOW LEVELS DETECTED COULD BE FROM SAMPLE HANDLING. MANUFACTURING RECORDS REVIEW: THE SERIAL NUMBER IS UNKNOWN, THEREFORE THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU STATES TO EXAMINE THE LENS THOROUGHLY TO ENSURE PARTICLES HAVE NOT BECOME ATTACHED TO IT, AND EXAMINE THE LENS OPTICAL SURFACES FOR OTHER DEFECTS. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL AR40E) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ABOUT 10 YEARS AGO. A VITREOUS OPERATION WAS PERFORMED ON (B)(6) 2017, AND THE VISUAL ACUITY GOT WORSE AS 20/16 ON (B)(6) 2017, 20/25 ON (B)(6) 2017, 20/200 ON (B)(6) 2018, 20/400 ON (B)(6) 2018. REPORTEDLY, THE LENS WAS WHITE AND CLOUDY WHEN SEEN UNDER THE SLIT LUMP, SO IT WAS EXPLANTED ON (B)(6) 2018. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372467 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention