BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 7389585 · Received April 2, 2018

    Report

    Report Number
    3011852734-2018-00038
    Event Type
    Injury
    Date Received
    April 2, 2018
    Report Date
    May 24, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474548671
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2018 AND (B)(6) 2018. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 4/30/2018. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION SHOWS THE PRODUCT WAS CUT IN HALF, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. THE REPORTED ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE WAS NOT VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (MODEL AAB00, +20.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE. THE LENS WAS SWITCHED TO SPECIALTY TELESCOPIC LENS FOR PATIENT'S MACULAR DEGENERATION. REPORTEDLY, DURING THE PROCEDURE THE INCISION WAS ENLARGED AND SUTURES WERE PLACED. THE PATIENT WAS REPORTED TO BE DOING WELL WHEN DISCHARGED. THERE WAS NO PATIENT INJURY, AND NO OTHER SURGICAL OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232017 SENSAR MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. AAB00 05050474548671

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention