BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ VIVITY EXTENDED VISION IOL

    MDR report key: 19871096 · Received July 31, 2024

    Report

    Report Number
    1119421-2024-01473
    Event Type
    Injury
    Date Received
    July 31, 2024
    Report Date
    November 7, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS AVAILABLE TO RETURN. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE LITERATURE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE COULD NOT BE DETERMINED. THE FILE HAS BEEN OPENED FROM A LITERATURE REPORT: VISION AND PATIENT-REPORTED OUTCOMES WITH NON-DIFFRACTIVE EXTENDED DEPTH OF FOCUS (ND-EDOF) OR NEUTRAL ASPHERIC MONOFOCAL INTRAOCULAR LENSES. THE ND-EDOF AND MONOFOCAL IOLS PROVIDED SIMILARLY EXCELLENT DISTANCE VISION. PATIENTS IMPLANTED WITH THE ND-EDOF IOL HAD 2 MORE LINES OF VISION AT BOTH INTERMEDIATE AND NEAR, AND A GREATER PROPORTION REPORTED SPECTACLE INDEPENDENCE. MOST PATIENTS IN BOTH GROUPS REPORTED LOW SEVERITY OF PHOTIC PHENOMENA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE RESEARCH ARTICLE WAS PUBLISHED WITH PURPOSE OF TO COMPARE OUTCOMES IN PATIENTS WHO UNDERWENT CATARACT EXTRACTION WITH IMPLANTATION OF NONDIFFRACTIVE EXTENDED DEPTH-OF-FOCUS (ND-EDOF; ALCON ACRYSOF VIVITY) OR NEUTRAL ASPHERIC MONOFOCAL (BAUSCH & LOMB ENVISTA) INTRAOCULAR LENSES (IOLS). SETTING: ACADEMIC MEDICAL CENTER. DESIGN: PROSPECTIVE SINGLE-CENTER DOUBLE-ARM PATIENT- AND ASSESSOR-MASKED RANDOMIZED CONTROLLED TRIAL. METHODS: PATIENTS WERE RANDOMIZED TO RECEIVE EITHER A ND-EDOF OR MONOFOCAL IOL IN BOTH EYES, TARGETED FOR EMMETROPIA. UNCORRECTED AND CORRECTED (CDVA) DISTANCE VISUAL ACUITIES, DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY (DCIVA), DISTANCE-CORRECTED NEAR VISUAL ACUITY (DCNVA), LEVEL OF SPECTACLE INDEPENDENCE, AND SEVERITY OF PHOTIC PHENOMENA WERE ASSESSED AT 3 MONTHS POSTOPERATIVELY. RESULTS: 56 PATIENTS WERE ENROLLED, OF WHICH 24 IN THE ND-EDOF GROUP AND 27 IN THE MONOFOCAL GROUP COMPLETED FOLLOW-UP. THE BINOCULAR MEAN CDVA, DCIVA, AND DCNVA WERE 20/20, 20/19, AND 20/21 FOR THE ND-EDOF IOL AND 20/18 (P EQUALS TO .188), 20/31 (P LESS THAN .001), AND 20/30 (P EQUALS TO .004) FOR THE MONOFOCAL IOL, RESPECTIVELY. AT INTERMEDIATE, 88 PERCENT OF THE ND-EDOF VS 30 PERCENT OF THE MONOFOCAL PATIENTS HAD A BINOCULAR DCIVA OF 20/25 OR BETTER (P LESS THAN .001). MODERATE OR SEVERE GLARE OCCURRED IN 20.8 PERCENT OF ND-EDOF VS 7.4 PERCENT OF MONOFOCAL PATIENTS (P EQUALS TO.228), WHEREAS MODERATE OR SEVERE HALOS OCCURRED IN 16.7 PERCENT OF ND-EDOF VS 11.1 PERCENT OF MONOFOCAL PATIENTS (P EQUALS TO .697). CONCLUSIONS: THE ND-EDOF AND MONOFOCAL IOLS PROVIDED SIMILARLY EXCELLENT DISTANCE VISION. PATIENTS IMPLANTED WITH THE ND-EDOF IOL HAD 2 MORE LINES OF VISION AT BOTH INTERMEDIATE AND NEAR, AND A GREATER PROPORTION REPORTED SPECTACLE INDEPENDENCE. MOST PATIENTS IN BOTH GROUPS REPORTED LOW SEVERITY OF PHOTIC PHENOMENA. THIS FILE BELONGS TO A PATIENT WHO HAD CYSTOID MACULAR EDEMA, TREATED AND RESOLVED WITHOUT SEQUELAE. PANTANELLI, SM, ET AL, VISION AND PATIENT-REPORTED OUTCOMES WITH NONDIFFRACTIVE EDOF OR NEUTRAL ASPHERIC MONOFOCAL INTRAOCULAR LENSES. JOURNAL OF CATARACT & REFRACTIVE SURGERY. 2023 APR; 49(4): 360-366.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913684 ACRYSOF IQ VIVITY EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON NI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O