BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_TECNIS SYMFONY

    MDR report key: 12208504 · Received July 22, 2021

    Report

    Report Number
    9614546-2021-07263
    Event Type
    Injury
    Date Received
    July 22, 2021
    Report Date
    July 22, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE, 62 - 76 YEARS. GENDER, BOTH MALES AND FEMALES. WEIGHT AND ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: ARTICLE ACCEPT DATE 27 JULY 2020. CATALOG # PARTIAL INFORMATION PROVIDED AS SERIAL NUMBER WAS NOT PROVIDED. SERIAL # INFORMATION UNKNOWN/ NOT PROVIDED. EXPIRATION DATE: UNKNOWN/ NOT PROVIDED AS SERIAL NUMBER WAS NOT PROVIDED. UDI # UNKNOWN/ NOT PROVIDED AS SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THERE IS NO INDICATION OF EXPLANT. DEVICE MANUFACTURING DATE: UNKNOWN NOT PROVIDED AS SERIAL NUMBER WAS NOT PROVIDED. MFR TELEPHONE: (B)(4). DEVICE EVALUATION: THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED, AND A FAILURE ANALYSIS CANNOT BE COMPLETED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS AND COMPLAINT HISTORY REVIEW COULD NOT BE CONDUCTED AS THE SERIAL NUMBERS WERE NOT PROVIDED. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. REINHARD, T., MAIER, P., BÖHRINGER, D., BERTELMANN, E., BROCKMANN, T., KIRALY, L., SALOM, D., PIOVELLA, M., COLONVAL, S. & MENDICUTE, J. (2020). COMPARISON OF TWO EXTENDED DEPTH OF FOCUS INTRAOCULAR LENSES WITH A MONOFOCAL LENS: A MULTI-CENTRE RANDOMISED TRIAL. GRAEFE'S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY (2021) 259:431¿442 HTTPS://DOI.ORG/10.1007/S00417-020-04868-5. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: COMPARISON OF TWO EXTENDED DEPTH OF FOCUS INTRAOCULAR LENSES WITH A MONOFOCAL LENS: A MULTI-CENTRE RANDOMISED TRIAL A PROSPECTIVE MULTI-CENTRE RANDOMIZED STUDY WAS DONE TO COMPARE TWO EXTENDED DEPTH OF FOCUS (EDOF) INTRAOCULAR LENSES (IOLS) AND ONE MONOFOCAL IOL. A TOTAL OF 211 PATIENTS WITH CLINICALLY SIGNIFICANT BILATERAL AGE-RELATED CATARACT WERE RANDOMIZED INTO THREE GROUPS: PATIENTS IMPLANTED WITH EITHER AT LARA 829MP (EDOF; N=78) (CARL ZEISSMEDITEC), THE TECNIS SYMFONY (EDOF; N=69) (JOHNSON & JOHNSON) OR THE CT ASPHINA 409MP (MONOFOCAL; N=68) (CARL ZEISS MEDITEC). AT 6 MONTHS POST-OP, 1.5% OF THE PATIENTS IMPLANTED WITH THE TECNIS SYMFONY DID NOT REACH THE ± 1.0 D TARGET. AT 6 MONTHS POST-OP, 9.8% OF PATIENTS IMPLANTED WITH TECNIS SYMFONY WERE SPECTACLE DEPENDENT FOR FAR DISTANCES, 13.8% WERE SPECTACLE DEPENDENT FOR INTERMEDIATE DISTANCES, AND 70.8% WERE SPECTACLE DEPENDENT FOR NEAR DISTANCES. POST-OPERATIVE COMPLICATIONS REPORTED DURING THE COURSE OF FOLLOW-UP WITH TECNIS SYMFONY INCLUDE PUNCTATE KERATITIS (N=6) AND CYSTOID MACULAR OEDEMA (N=4). AT 6 MONTHS FOLLOW UP WITH PATIENTS IMPLANTED WITH TECNIS SYMFONY, 13.6% WERE HAVING DIFFICULTY WITH DAILY ACTIVITIES, 40.9% WERE HAVING DIFFICULTY DOING WORK OR HOBBIES THAT REQUIRE TO SEE WELL UP CLOSE, 45.5% WERE HAVING DIFFICULTY READING ORDINARY PRINT IN NEWSPAPERS, 74.2% WERE HAVING DIFFICULTY READING THE SMALL PRINT IN A TELEPHONE BOOK, ON A MEDICINE BOTTLE OR ON LEGAL FORMS, 9.3% WERE HAVING DIFFICULTY DRIVING DURING THE DAYTIME IN FAMILIAR PLACES, AND 30.2% WERE HAVING DIFFICULTY DRIVING AT NIGHT. ADDITIONALLY, 33.8% OF PATIENTS IMPLANTED WITH TECNIS SYMFONY WERE OBSERVING SYMPTOMS OF GLARE, 40.9% WERE OBSERVING SYMPTOMS OF HALOS, AND 38.5% WERE OBSERVING SYMPTOMS OF STARBURSTS. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105398 UNK_TECNIS SYMFONY EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention