BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 10021892 · Received May 4, 2020

    Report

    Report Number
    2648035-2020-00404
    Event Type
    Injury
    Date Received
    May 4, 2020
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED IN THE INITIAL MDR, DATE RECEIVED BY MANUFACTURER WAS INADVERTENTLY POPULATED WITH 4/9/2020. THE CORRECT DATE AWARE FOR THE INITIAL REPORT IS 4/7/2020. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGES/DATES OF BIRTH: EXACT AGES NOT PROVIDED ONLY GREATER THAN OR EQUAL TO 65 YEARS OLD PROVIDED. SEXES/GENDERS: UNKNOWN/ NOT PROVIDED. DATES OF EVENT: UNKNOWN, NOT PROVIDED. PARTIAL CATALOG#: UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. SERIAL NUMBERS: UNKNOWN, INFORMATION NOT PROVIDED. UNIQUE DEVICE IDENTIFIERS (UDI #''S): UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. EXPIRATION DATES: UNKNOWN, AS SERIAL NUMBERS WERE NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBERS WERE NOT PROVIDED. (B)(4). DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED; THEREFORE, THE COMPLAINT ISSUE REPORTED WAS NOT VERIFIED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS REVIEW WAS NOT PERFORMED AS NO SERIAL NUMBER WAS PROVIDED. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS WAS NOT PERFORMED AS NO SERIAL NUMBER WAS PROVIDED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A QUALITY PRODUCT DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. CITATION: AMERICAN ACADEMY OF OPHTHALMOLOGY. ND:YAG LASER POSTERIOR CAPSULOTOMY. HTTPS://WWW.AAO.ORG/MUNNERLYN-LASER-SURGERY-CENTER/NDYAG-LASER-POSTERIOR-CAPSULOTOMY-3. ACCESSED 04 NOV 2013. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ALTHOUGH NO SPECIFIC INTRAOCULAR LENS (IOL) MODELS WERE DESCRIBED, THE AUTHOR MENTIONED THAT 1060 EYES OUT OF 15,083 IMPLANTED EXPERIENCED POSTERIOR CAPSULAR OPACIFICATION (PCO) AT 3 YEAR FOLLOW UP AND 553 AT 5 YEAR FOLLOW UP, IT ALSO DESCRIBES THAT 770 AND 477 RESPECTIVELY WERE TREATED WITH YTTRIUM-ALUMINUM GARNET (YAG) CAPSULOTOMY; HOWEVER, IT IS NOT DESCRIBED IF THE YAG TREATMENT WAS DUE TO A DECREASE OF GREATER THAN OR EQUAL TO 2 LINES IN BEST CORRECTED VISUAL ACUITY (BCVA) OR DEBILITATING SYMPTOMS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486309 TECNIS MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention