BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_TECNIS SYMFONY

    MDR report key: 16440793 · Received February 24, 2023

    Report

    Report Number
    3012236936-2023-00489
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    May 10, 2022
    Report Date
    February 24, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE, MEAN (SD): 68.6 (7.7)A GENDER: FEMALE: 25,275 (60.2)A, MALE: 16,742 (39.8) WEIGHT: UNKNOWN, INFORMATION NOT PROVIDED. ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. RACE, N (%): WHITE: 34,899 (83.1)A, BLACK: 1292 (3.1), OTHER OR NOT REPORTED: 5826 (13.9) DATE OF EVENT: EXACT DATES NOT PROVIDED; ARTICLE ACCEPTANCE DATE IS (B)(6) 2022. BRAND NAME: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. ONLY PROVIDED AS TECHNICS SYNONYM. MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE DEVICE WAS EXPLANTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. HEALTH EFFECT - CLINICAL CODE: 4581 - THIS CODE WAS USED FOR THE REPORTED POSTERIOR CAPSULAR OPACIFICATION (PCO). CITATION: HORN JD, FISHER BL, TERVEEN D, FEVRIER H, MERCHEA M, GU X. (2022). ACADEMY IRIS® REGISTRY ANALYSIS OF INCIDENCE OF LASER CAPSULOTOMY DUE TO POSTERIOR CAPSULE OPACIFICATION AFTER INTRAOCULAR LENS IMPLANTATION. CLINICAL OPHTHALMOLOGY 16, PP.1721-1730. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; 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

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW: ARTICLE: ACADEMY IRIS® REGISTRY ANALYSIS OF INCIDENCE OF LASER CAPSULOTOMY DUE TO POSTERIOR CAPSULE OPACIFICATION AFTER INTRAOCULAR LENS IMPLANTATION A RETROSPECTIVE DATABASE ANALYSIS USING DATA FROM THE IRIS (INTELLIGENT RESEARCH IN SIGHT) REGISTRY WAS DONE TO DETERMINE THE INCIDENCE OF POSTOPERATIVE NEODYMIUM DOPED YTTRIUM ALUMINUM GARNET LASER CAPSULOTOMY (ND:YAG) AND TIME TO POSTERIOR CAPSULAR OPACIFICATION (PCO) DIAGNOSIS BASED ON INTRAOCULAR LENS (IOL) TYPE AND BRAND. A TOTAL OF 89,947 EYES (N=89,947 EYES) INCLUDED HAD CATARACT SURGERY AND WERE IMPLANTED WITH INTRAOCULAR LENS (IOL) BY OPTICAL TYPE (MONOFOCAL, N=57, 523 EYES; AND MULTIFOCAL OR DIFFRACTIVE EXTENDED DEPTH OF FOCUS (EDOF), N=32, 424 EYES) AND 1 OF 2 BRANDS USED, ACRYSOF® (ALCON RESEARCH LLC, FORT WORTH, TX, USA) (N=47,930 EYES, 53.3%); OR TECHNICS® (JOHNSON & JOHNSON SURGICAL VISION, SANTA ANA, CA, USA)(N=42,017 EYES, 46.7%). ANALYSES INCLUDED THE MEAN TIME TO PCO DIAGNOSIS AND ND:YAG TREATMENT WITHIN 365 DAYS AFTER IOL IMPLANTATION. IT WAS REPORTED THAT THERE WERE PCO DIAGNOSIS WITHIN 365 DAYS (N=24,834, 28%) AND HAD UNDERWENT ND:YAG (N=9,262, 10.3%); THOSE WITH TECHNICS IOLS THAT UNDERWENT ND:YAG WERE MONOFOCAL (8.1%) AND DIFFRACTIVE MULTIFOCAL (MF) (22.5%) OR DIFFRACTIVE EXTENDED DEPTH OF FOCUS (EDOF) IOLS (21.5%). THERE WERE NO FURTHER INTERVENTIONS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT IS FOR THE TECHNICS SYNONYM INTRAOCULAR LENS (IOL) ADVERSE EVENT. SEPARATE REPORTS ARE BEING SUBMITTED TO CAPTURE THE REPORTED EVENTS WITH THE MONOFOCAL AND MULTIFOCAL LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994169 UNK_TECNIS SYMFONY EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention