BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 4922544 · Received July 17, 2015

    Report

    Report Number
    2648035-2015-00454
    Event Type
    Injury
    Date Received
    July 17, 2015
    Report Date
    June 24, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED IMPLANTS WERE FROM 2009 TO 2013. THERE WAS NO INFORMATION INDICATING THE LENSES WERE EXPLANTED. VARIOUS AUTHORS: CLARE KIRWAN, JOHN M. NOLAN, JIM STACK, TARA C.B. MOORE, STEPHEN BEATTY (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PROVIDED IN THE LITERATURE ARTICLE: DETERMINANTS OF PATIENT SATISFACTION AND FUNCTION RELATED TO VISION FOLLOWING CATARACT SURGERY IN EYES WITH NO VISUALLY CONSEQUENTIAL OCULAR CO-MORBIDITY. PURPOSE: TO INVESTIGATE SUBJECTIVELY REPORTED OUTCOMES FOLLOWING CATARACT SURGERY AND THE RELATIONSHIPS BETWEEN SUCH OUTCOMES IN THE CONTEXT OF FALLING THRESHOLDS FOR CATARACT SURGERY. METHODS: PRE-OPERATIVE, INTRA-OPERATIVE AND POST-OPERATIVE DATA OF 2552 EYES UNDERGOING PHACOEMULSIFICATION AND IMPLANTATION OF THE TECNIS ZCB00 1-PIECE INTRAOCULAR LENS (IOL) BY A SINGLE SURGEON BETWEEN JULY 2009 AND OCTOBER 2013 WERE ANALYZED. OF THE 2552 PROCEDURES, AN INTRA-OPERATIVE COMPLICATION OCCURRED IN 16 (0.06%) PROCEDURES. THE MOST COMMON INTRA-OPERATIVE COMPLICATIONS WERE POSTERIOR CAPSULE RUPTURE WITH VITREOUS LOSS, ALL OF WHICH REQUIRED ANTERIOR VITRECTOMY (0.16%, BUT REPRESENTING 25% OF INTRAOPERATIVE COMPLICATIONS); ZONULAR DIALYSIS (0.16% BUT REPRESENTING 25% OF COMPLICATIONS); IRIS TRAUMA (0.12% OF PROCEDURES, REPRESENTING 18.75% OF INTRA-OPERATIVE COMPLICATIONS). POST OPERATIVE COMPLICATIONS WERE SEEN IN 168 CASES (6.6% OF TOTAL PROCEDURES), THE MOST COMMON BEING PSEUDOPHAKIC CYSTOID MACULAR EDEMA (CMO), WHICH OCCURRED FOLLOWING 87 (3.4%) PROCEDURES. RESULTS AND CONCLUSION: POST-OP COMPLICATIONS WERE POSTERIOR CAPSULE RUPTURE, ZONULAR DIALYSIS, IRIS TRAUMA, AND PSEUDOPHAKIC CMO (CYSTOID MACULAR OEDEMA). HOWEVER, 54.8% OF RESPONDENTS WERE ENTIRELY SATISFIED POST-OP. SATISFACTION WAS POSITIVELY ASSOCIATED WITH PATIENT AGE AND NEGATIVELY ASSOCIATED WITH SPECTACLE DEPENDENCE, DYSPHOTOPSIA AND FUNCTION RELATED TO VISION SCORE. THE ZCB00 LENS IS SHOWN TO BE A SAFE LENS WITH GOOD REFRACTIVE OUTCOMES, HIGH SATISFACTION RATES AND LOW RISK OF DYSPHOTOPSIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464955 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other