BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 5496969 · Received March 14, 2016

    Report

    Report Number
    9614546-2016-00107
    Event Type
    Injury
    Date Received
    March 14, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE DOES NOT REPORT EXPLANTS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED, THEREFORE THE ISSUE COULD NOT BE VERIFIED. THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: EVALUATION OF THE ASPHERIC TECNIS MULTIFOCAL INTRAOCULAR LENS: ONE-YEAR RESULTS FROM THE FIRST COHORT OF THE FOOD AND DRUG ADMINISTRATION CLINICAL TRIAL: AM J OPHTHALMOL 2010;149:577-584. 2010 BY (B)(4)-. PAGE 577- PURPOSE: TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE ASPHERIC DIFFRACTIVE TECNIS MULTIFOCAL ZM900 (TCMF) INTRAOCULAR LENS (IOL; ABBOTT MEDICAL OPTICS, INC.,(B)(4)) SUBJECTS UNDERWENT BILATERAL IMPLANTATION WITH THE TCMF IOL OR THE CEEON 911A MONOFOCAL (CEMN) IOL (ABBOTT MEDICAL OPTICS, INC) ACCORDING TO SUBJECT PREFERENCE. RESULTS: ONE-YEAR RESULTS WERE AVAILABLE FOR 244 EYES OF 125 TCMF IOL SUBJECTS AND FOR 245 EYES OF 123 CEMN IOL SUBJECTS. MEAN DISTANCE VISUAL ACUITIES (VAS) WERE STATISTICALLY AND CLINICALLY EQUIVALENT BETWEEN THE 2 GROUPS. PAGE 579 RESULTS: ONE-YEAR DATA AS OF FEBRUARY 27, 2007, WERE AVAILABLE FROM 94.3% (116/123) OF CEMN IOL SUBJECTS. SEVEN CEMN IOL SUBJECTS WERE NOT INCLUDED BECAUSE OF DECLINING TO PARTICIPATE FURTHER (N=3), DEATH (N=1), ILLNESS (N=2), AND LOSS TO FOLLOW-UP (N=1). ADDITIONAL SURGICAL PROCEDURES OR COMPLICATIONS WERE RARE FOR EITHER LENS GROUP. THERE WERE NO LENS EXPLANTATIONS OR EXCHANGES IN THE CEMN IOL GROUP. PAGE 581- FOR EACH EYE, SUBJECTS WERE ASKED BY INVESTIGATORS IF THEY WERE HAVING DIFFICULTIES WITH THEIR VISION. FOR CEMN IOL FIRST EYES, THE MOST REPORTED OPTICAL OR VISUAL SYMPTOM AT 1 YEAR ALSO WAS HALOS (8.6% [10/116]), WITH MOST REPORTS BEING MILD IN SEVERITY. NIGHT GLARE WAS REPORTED BY 4.3% (5/116) CEMN IOL SUBJECTS. THE MOST COMMON REASON FOR NOT ELECTING THE SAME IOL AGAIN WAS POOR NEAR VISION, ALL FROM CEMN IOL SUBJECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155825 CEEON MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS 911A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other