BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 5632365 · Received May 4, 2016

    Report

    Report Number
    1119421-2016-00699
    Event Type
    Injury
    Date Received
    May 4, 2016
    Report Date
    August 10, 2016
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND EMAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED IN DEVICE AVAILABLE FOR EVALUATION?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. PRODUCT EVALUATION: THE IOL WAS RETURNED WITH SOLUTION AND AREAS OF OPTIC DAMAGE. THE EDGE WAS SPLIT/CUT THROUGH THE CENTRAL OPTIC ZONE. A DIMENSIONAL INSPECTION WAS CONDUCTED USING AN APPROVED TEMPLATE. THE LENS DIMENSIONS MET SPECIFICATIONS PER THE APPROVED TEMPLATE. THE CUSTOMER INDICATED THE USE OF AN APPROVED CARTRIDGE AND HANDPIECE. THE 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. TWO VISCOELASTICS WERE INDICATED, ONLY ONE IS QUALIFIED FOR THIS LENS/CARTRIDGE COMBINATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT OF EDGES FLARED OUT, DID NOT SIT RIGHT, RUBBED ON IRIS. THE LENS DIMENSIONS ARE ACCEPTABLE (PLAN VIEW) USING AN APPROVED TEMPLATE. THE RETURNED LENS OPTIC SURFACE AND EDGE WAS DAMAGED. THE EDGE OF THE LENS WAS CUT INTO THE CENTER OF THE OPTIC, AND THIS DAMAGE IS SIMILAR TO DAMAGE THAT CAN BE CREATED WHEN REMOVING AN IOL FROM THE EYE. WE ARE UNABLE TO CONFIRM IF THE QUALIFIED VISCOELASTIC WAS USED WITH THE LENS/CARTRIDGE COMBINATION. DUE TO DIFFERING MATERIAL PROPERTIES, THE USE OF A NON-QUALIFIED VISCOELASTIC MAY RESULT IN DELIVERY ISSUES AND/OR DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS (IOL) THAT WAS BLURRY/SCRATCHED AND WAS "EXCHANGED". ADDITIONAL INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT THE LENS WAS EXCHANGED IN A SECOND PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY A SCRUB TECHNICIAN THAT THE LENS EDGES FLARED OUT, DID NOT SIT RIGHT IN THE EYE, AND RUBBED ON THE IRIS. THE PATIENT EXPERIENCED BLURRED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287548 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SN6AD1 12374534

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other| R