BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 17015030 · Received May 26, 2023

    Report

    Report Number
    3012236936-2023-01339
    Event Type
    Injury
    Date Received
    May 26, 2023
    Report Date
    June 22, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH A FOLLOW UP WITH THE DOCTOR, HE INDICATED THAT THERE ARE NO UPDATES AT THE MOMENT. HE HAS NOT SEEN THE PATIENT BACK YET TO GO OVER THE PATIENT'S OPTIONS FOR THE OTHER EYE. THE DOCTOR IS GOING TO RECOMMEND IMPLANTING A SYMPHONY IN THE PATIENT'S OPPOSITE EYE AND SEE HOW SHE DOES. IF THE PATIENT LIKES THAT VISION MORE THAN THE SYNERGY, THE DOCTOR WILL OFFER A LENS EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION D1: BRAND NAME: TECNIS IOL SECTION D2: COMMON DEVICE NAME: LENS, MULTIFOCAL INTRAOCULAR SECTION D2: DEVICE PRODUCT CODE: MFK SECTION D4: MODEL NUMBER: UNK_TECNIS SYNERGY SECTION D4: CATALOG NUMBER: UNK-TECNIS SYNERGY_UNKNOWN CORRECTED DATA: BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE FOLLOWING INFORMATION ENTERED IN THE INITIAL MDR REPORT NO LONGER APPLICABLE TO THIS CASE: SECTION D1: BRAND NAME: UNK_MONOFOCAL IOL SECTION D2: COMMON DEVICE NAME: INTRAOCULAR LENS SECTION D2: DEVICE PRODUCT CODE: HQL SECTION D4: MODEL NUMBER: UNK-MONOFOCAL IOL SECTION D4: CATALOG NUMBER: UNK-MONOFOCAL IOL_UNKNOWN ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4, AND A5: UNKNOWN, INFORMATION WAS NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATE IS UNKNOWN/NOT PROVIDED. IT WAS INDICATED THAT THE DEPTH PERCEPTION COMPLAINT STARTED ON FIRST DAY. SECTION D4: MODEL NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: CATALOG#: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: THE UNIQUE IDENTIFIER (UDI) NUMBER IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: LENS REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. SECTION H3 - OTHER (81): THE LENS WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THERE WAS NO MODEL OR SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2137 (CAPTURES BOTH HM-POOR NEAR VISION AND HM-BLURRED VISION). SECTION H6: HEALTH EFFECT - CLINICAL CODE: 4581 (CAPTURES HM-PCO : POSTERIOR CAPSULE OPACIFICATION). ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAS HIGH MYOPIA. THE PATIENT HAS GOOD REFRACTIVE RESULT IF NOT A LITTLE HYPEROPIC AFTER FIRST EYE (+0.25-+0.50). BIGGEST COMPLAINT IS THAT THERE IS NO NEAR VISION AND THE DEPTH PERCEPTION IS SO BAD THAT THE PATIENT CAN BARELY WALK AROUND OR GO UPSTAIRS. DISTANCE IS A LITTLE BLURRY AS WELL, BUT THERE IS ALREADY SOME CAPSULAR OPACITY. THE DEPTH PERCEPTION COMPLAINT STARTED ON FIRST DAY. THE PATIENT DOES NOT WANT TO HAVE CATARACT SURGERY ON THE OTHER EYE UNTIL THE FIRST ONE IS BETTER, AND THIS ISSUE IS RESOLVED. REPORTEDLY, THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH PATIENT¿S DAILY ACTIVITY. THE INTRAOCULAR LENS REMAINS IMPLANTED, AND NO INTERVENTIONS WERE INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062607 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. UNK-TECNIS SYNERGY
    1886407 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. UNK-TECNIS SYNERGY

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other