BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 11824925 · Received May 14, 2021

    Report

    Report Number
    1119421-2021-01033
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 1, 2021
    Report Date
    October 25, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN H.6. FDA PATIENT CODES HAVE BEEN UPDATED. ADDITIONAL INFORMATION PROVIDED IN H.10. THE FILE INDICATES THE USE OF A COMPANY HANDPIECE. WITHOUT THE CARTRIDGE MODEL IT CANNOT BE DETERMINED IF THIS IS A QUALIFIED COMBINATION. THE FILE WAS OPENED FROM A LITERATURE REPORT: REFRACTIVE LENS EXCHANGE IN HYPEROPIC PRESBYOPES WITH THE COMPANY LENS INTRAOCULAR LENS: ONE-YEAR RESULTS AND ANALYSIS OF THE LITERATURE. THE STUDY CONCLUDED THAT THE COMPANY TRIFOCAL ARTIFICIAL LENS OFFERS A GOOD VISION AT DISTANCE, INTERMEDIATE AND NEAR, WITH A GOOD QUALITY OF VISION AND REFRACTION. NOT ENOUGH INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    IN THE PREVIOUS REPORT THE OUTCOME OF THE EVENT WAS CAPTURED AS OTHER MEDICALLY SIGNIFICANT INSTEAD OF REQUIRED MEDICAL OR SURGICAL INTERVENTION. LITERATURE REPORT HAS BEEN ATTACHED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. LITERATURE ARTICLE: ARIADNA NICULA, CRISTINA. REFRACTIVE LENS EXCHANGE IN HYPEROPIC PRESBYOPES WITH THE ACRYSOF IQ PANOPTIX INTRAOCULAR LENS: ONE-YEAR RESULTS AND ANALYSIS OF THE LITERATURE. DOVE PRESS JOURNAL: THERAPEUTICS AND CLINICAL RISK MANAGEMENT. 2020:16 1125¿1137. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE ENTITLED "REFRACTIVE LENS EXCHANGE IN HYPEROPIC PRESBYOPES WITH THE ACRYSOF IQ PANOPTIX INTRAOCULAR LENS: ONE-YEAR RESULTS AND ANALYSIS OF THE LITERATURE" THE AUTHORS ASSESS THE FUNCTIONAL AND REFRACTIVE OUTCOMES IN HYPEROPIA AND PRESBYOPIA CORRECTION BY CLEAR LENS EXCHANGE WITH THE INTRAOCULAR TRIFOCAL ARTIFICIAL LENS (IOL) IMPLANT AT 1 YEAR. 64 PATIENTS (128 EYES) UNDERWENT CLEAR LENS EXCHANGE WITH PLACEMENT OF THE TRIFOCAL IOL IMPLANT FOR HYPEROPIA AND PRESBYOPIA. IN ALL CASES THE ARTIFICIAL LENS WAS IMPLANTED IN THE BAG WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. SOME PATIENTS EXPERIENCED GLARE, HALOS, MYOPIC SHIFT/OUTCOME, POSTERIOR CAPSULE OPACIFICATION, WEAK CONTRAST SENSITIVITY, VISUAL DISTURBANCES AND GLITTERING DURING NIGHT TIME POSTOPERATIVELY. YTTRIUM ALUMINUM GARNET (YAG) LASER CAPSULOTOMY WAS PERFORMED FOR PATIENTS WITH POSTERIOR CAPSULE OPACIFICATION AND ONE PATIENT HAD CORNEAL REFRACTIVE SURGERY WITH EXCIMER LASER. IT WAS NOTED THAT THE IOL OFFERS A GOOD VISION AT DISTANCE, INTERMEDIATE AND NEAR, WITH A GOOD QUALITY OF VISION AND REFRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721820 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT00 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CENTURION VS| MONARCH IOL INJECTOR| OXIBUPROCAIN SOLUTION| CENTURION VS| MONARCH IOL INJECTOR| OXIBUPROCAIN SOLUTION