BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_SENSAR

    MDR report key: 14479992 · Received May 23, 2022

    Report

    Report Number
    3012236936-2022-01353
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Report Date
    June 20, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. DATE OF EVENT: UNKNOWN, AS THE DATE INCIDENT OCCURRED WAS NOT PROVIDED. ADDITIONAL DEVICE INFORMATION. MODEL NUMBER: UNKNOWN/NOT PROVIDED. CATALOG NUMBER: UNKNOWN/NOT PROVIDED. SERIAL NUMBER: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS SERIAL NUMBER HAS NOT BEEN PROVIDED. UNIQUE IDENTIFIER (UDI) NUMBER: UNKNOWN AS SERIAL NUMBER HAS NOT BEEN PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; 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 WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE COMPLAINT; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON FOLLOWING THE COMPANY REPRESENTATIVE'S ADVICE OF FILLING THE CARTRIDGES COMPLETELY WITH HEALON, THE CUSTOMER CONFIRMS NO LONGER OBSERVING THE PROBLEM OR THAT THE HAPTICS BECOME UNSTUCK WITHIN A FEW SECONDS AFTER IMPLANTATION. BASED ON THIS, THE CUSTOMER THINKS THAT IT WAS A HANDLING ERROR. THEREFORE UPON REVIEW OF THE NEW INFORMATION, THE COMPLAINT IS ASSESSED AS NO LONGER CONSIDERED REPORTABLE. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2022-01353. THE FIELD BELOW IS UPDATED: SECTION H6: MEDICAL DEVICE PROBLEM CODE: 1670. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SURGEON AS A GENERAL REMARK THAT THE HAPTICS OF THE GAB SENSAR 1-PIECE INTRAOCULAR LENS (IOL) STICK TOGETHER AFTER IMPLANTATION AND THAT THEY CAN OFTEN ONLY BE DETACHED FROM EACH OTHER BY USING DIFFERENT INSTRUMENTS. THIS DOES NOT CONCERN A SPECIFIC LENS. THROUGH FOLLOW UPS IT WAS CONFIRMED THAT THERE WAS NO COMPLICATION DUE TO THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207638 UNK_SENSAR INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown