BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 4791655 · Received May 22, 2015

    Report

    Report Number
    1119421-2015-05426
    Event Type
    Injury
    Date Received
    May 22, 2015
    Report Date
    August 11, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE JOURNAL ARTICLE DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ADDITIONAL INFORMATION IS NOT EXPECTED. VAN DER MOOREN, M. (2015). EXPLANTED MULTIFOCAL INTRAOCULAR LENSES. JOURNAL OF CATARACT AND REFRACTIVE SURGERY, 41, 873-877. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION PROVIDED. ARTICLE ATTACHED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE REPORTED A CASE IN WHICH A SINGLE-PIECE ACRYLIC INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE OF COMPLICATIONS RELATED TO THE PRESENCE OF DENSE GLISTENINGS IN THE BULK OF THE IOL OPTIC. THE PATIENT COMPLAINED ABOUT BLURRY OR HAZY VISION, DIFFICULTY READING AND DRIVING, GLARE AND HALOS. THE PATIENT WAS DIAGNOSED WITH AGE RELATED MACULAR DEGENERATION AS WELL AS PERIPHERAL POSTERIOR CAPSULE OPACIFICATION. SYMPTOMS RESOLVED FOLLOWING A LENS EXCHANGE. ADDITIONAL INFORMATION IS NOT EXPECTED.

    Description of Event or Problem · 1

    CORRECTION: THE PATIENT DID NOT EXPERIENCE HALOS AS WAS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336375 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SN6AD3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R