BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR

    MDR report key: 8625180 · Received May 20, 2019

    Report

    Report Number
    3011852734-2019-00109
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 22, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474548725
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 5/6/2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE PRODUCT WAS RECEIVED IN A PLASTIC SAMPLE VIAL ALONG WITH ITS ORIGINAL BOX BOTH KEPT INSIDE A RESEALABLE PLASTIC BIOHAZARD SPECIMEN BAG. A VISUAL INSPECTION OF THE LENS SHOWS IT WAS CUT INTO THREE PIECES. TRACES OF OVD OR BSS WERE VISIBLE ON THE LENS SURFACES. THE CONDITION OF THE LENS IS CONSISTENT WITH A LENS THAT HAS BEEN HANDLED, CUT, AND REMOVED. THE COMPLAINT EVENT COULD NOT BE CONFIRMED. RETURNED SAMPLE EVALUATION PERFORMED. THE PRODUCT WAS FORWARDED TO AN EXTERNAL LAB FOR ADDITIONAL MATERIAL ANALYSIS OF THE OBSERVED RESIDUE. RESULTS RECEIVED INDICATE THE FTIR SPECTRUM SHOWS THE RESIDUE IS CONSISTENT WITH INORGANIC SALTS SIMILAR TO SODIUM HYALURONATE. MANUFACTURING RECORD REVIEW: HE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS RESIDUE ON INTRAOCULAR LENS. THERE WAS PATIENT CONTACT AND NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT LENS WAS NOT INSERTED, REMOVED AND REPLACED. NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY WAS REQUIRED. PATIENT WAS DOING GOOD. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418177 SENSAR MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. AAB00 05050474548725

    Patients

    Seq Age Sex Outcome Treatment
    1