BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 19904738 · Received August 5, 2024

    Report

    Report Number
    1119421-2024-01510
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Report Date
    November 4, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. 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. ROOT CAUSE HAS NOT BEEN IDENTIFIED. LITERATURE CITATION- AUFFARTH GU, ET AL. RANDOMIZED MULTICENTER TRIAL TO ASSESS POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS IN TWO HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES. NATURE PORTFOLIO SCIENTIFIC REPORT.2023;13:1-9. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3. AND H.11. CORRECTION INFORMATION PROVIDED IN H.6. CORRECTION: ON INITIAL MDR THE CODES SHOULD HAVE BEEN METHOD CODES B20 AND B22. RESULT CODE C20 AND CONCLUSION CODE D15. THE FILE HAS BEEN OPENED FROM A LITERATURE REPORT: RANDOMIZED MULTICENTER TRIAL TO ASSESS POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS IN TWO HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES. TO EVALUATE THE LONG-TERM POSTERIOR CAPSULE OPACIFICATION (PCO) FORMATION, AND GLISTENING RATE OF THE NON COMPANY (XY1) IOL COMPARED TO COMPANY LENS. THERE WERE NO REPORTS OF ADVERSE EVENTS LEADING TO LENS REMOVAL OR UNANTICIPATED ADVERSE DEVICE EFFECTS IN EITHER GROUP. THERE WERE NO REPORTS OF ANY PERSISTENT ADVERSE EVENTS. NO SERIOUS ADVERSE DEVICE EFFECTS RELATED TO THE IOLS WERE REPORTED DURING THE STUDY. IN CONCLUSION, THE RESULTS OF THIS 3-YEAR STUDY SHOWED COMPARABLE INCIDENCE OF VERY LOW AMOUNTS OF PCO IN EYES IMPLANTED WITH BOTH IOLS, RESULTING FROM THE SUBJECTIVE EVALUATION OF PCO AND EPCO ANALYSIS. OVER THE STUDY PERIOD, ND: YAG LASER CAPSULOTOMY WAS REQUIRED FOR ONE EYE IMPLANTED WITH THE COMPANY IOL. LITERATURE CITATION- AUFFARTH GU, ET AL. RANDOMIZED MULTICENTER TRIAL TO ASSESS POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS IN TWO HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES. NATURE PORTFOLIO SCIENTIFIC REPORT.2023;13:1-9. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    THE RESEARCH ARTICLE PUBLISHED WITH A PURPOSE TO EVALUATE THE LONG-TERM POSTERIOR CAPSULE OPACIFICATION (PCO) FORMATION, AND GLISTENING RATE OF THE HOYA VIVINEX (XY1) IOL COMPARED TO ALCON ACRYSOF (SN60WF). THE STUDY WAS CONDUCTED IN 87 SUBJECTS THAT UNDERWENT CATARACT SURGERY WITH IOL IMPLANTATION, WITH 67 PATIENTS COMPLETING THE 3-YEAR FOLLOW-UP. THE COMPLETER POPULATION CONSISTED OF 32 SUBJECTS IMPLANTED WITH XY1 AND 35 IMPLANTED WITH SN60WF. PRIMARY ENDPOINTS CONSISTED OF THE EVALUATION OF GLISTENINGS AND MEASUREMENT OF PCO. SECONDARY OUTCOMES INCLUDED BEST CORRECTED DISTANCE VISUAL ACUITY (BCVA), CONTRAST ACUITY (CA), UNCORRECTED VISUAL ACUITIES, SUBJECTIVE REFRACTION, MEDICAL AND LENS COMPLICATION RATES, ADVERSE EVENTS, AND OPTICAL/VISUAL SYMPTOMS. FOLLOW-UP VISITS OCCURRED AT 6-MONTHS, 1-, 2- AND 3-YEARS. THE STUDY RESULTS STATED AT 3-YEARS FOLLOW-UP, MEAN PCO SCORE WAS 0.121 ± 0.193 FOR EYES IMPLANTED WITH VIVINEX VERSUS 0.239 ± 0.463 FOR ACRYSOF (P = 0.026). THE VIVINEX IOL SHOWED STATISTICALLY SIGNIFICANTLY LOWER GLISTENING OCCURRENCE THROUGH 3-YEARS POSTOPERATIVELY (0.14 ± 0.26) COMPARED TO ACRYSOF (1.79 ± 1.43; P < 0.0001). POSTOPERATIVE VISUAL ACUITIES IMPROVED FROM BASELINE IN BOTH IOL GROUPS (P < 0.0001), AND REMAINED STABLE THROUGH THE 3-YEAR FOLLOW-UP PERIOD. THE STUDY WAS CONCLUDED AS EYES IMPLANTED WITH A HOYA VIVINEX IOL EXHIBITED SIGNIFICANTLY LOWER OCCURRENCE OF GLISTENING AT 3-YEARS VERSUS ALCON ACRYSOF (P < 0.0001). INCIDENCE OF PCO WAS VERY LOW AND COMPARABLE IN BOTH VIVINEX AND ACRYSOF EYES. THIS FILE BELONGS TO 59 PATIENTS IN WHICH GLISTENING WAS DETECTED AFTER ALCON ACRYSOF LENS IMPLANTATION. AUFFARTH GU, ET AL. RANDOMIZED MULTICENTER TRIAL TO ASSESS POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS IN TWO HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES. NATURE PORTFOLIO SCIENTIFIC REPORT.2023;13:1-9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274672 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown