BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4008696 · Received July 22, 2014

    Report

    Report Number
    1119421-2014-00553
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    January 6, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THE IOL PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. MONARCH PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CUSTOMER INDICATED USE OF AN APPROVED CARTRIDGE WITH AN UNK HANDPIECE. IT IS UNK IF THE APPROVED COMPONENT OF THE VISCOELASTIC WAS USED. THIS REPORT WAS MAILED TO FDA ON 08/22/2014. THE MFR INTERNAL REF NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    MFR INTERNAL REF NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    F/U REPORTS 01 AND 02 WERE SUBMITTED WITH INACCURATE MFR REPORT# 9612169-2014-00077. THE CORRECT NUMBER SHOULD MATCH THE INITIAL MDR AS 111421-2014-00553. THE MFR INTERNAL REF NUMBER IS: (B)(4)..

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT AFTER AN IOL IMPLANTATION, SHE SAW A SPOT IN THE MIDDLE OF THE IOL (WHICH LOOKED LIKE A "PRETZEL"), A SHADOW AND DIFFICULTIES IN VISION. THE PATIENT CONSULTED ANOTHER DOCTOR TO GET A SECOND OPINION AND THAT DOCTOR DIAGNOSED A NEGATIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON WHO CONFIRMED THAT ON THE RIGHT EYE, THERE IS A "PRETZEL" LIKE SHAPE PRESENT IN THE CENTRAL VISUAL FIELD. ON BOTH EYES, THERE IS PERIPHERAL LIMITATION, LIKE A FRAME. ACCORDING TO THE SURGEON, THE "FRAMES" ARE PROBABLY CAUSED BY THE CHANGE OF THE PERIPHERAL LIGHT PATH AT THE POSTERIOR CHAMBER LENS.

    Description of Event or Problem · 1

    ADD'L INFO WAS PROVIDED BY THE SURGEON INDICATING THAT THE SPOT IN THE MIDDLE OF THE IOL DESCRIBED AS A "PRETZEL" WAS FIXED. NO CAUSE OR DIAGNOSIS WAS PROVIDED AS ACCORDING TO THE SURGEON FURTHER INVESTIGATIONS WERE REJECTED.

    Description of Event or Problem · 1

    ADD'L INFO WAS RECEIVED FROM THE FACILITY WHO REPORTED THAT THE IOL WAS EXPLANTED AND ANOTHER IOL FROM ANOTHER MFR WAS IMPLANTED. AFTER THE EXPLANTATION ALL THE SYMPTOMS DISAPPEARED.

    Description of Event or Problem · 1

    ADD'L RECEIVED FROM THE CONSUMER INDICATED THAT THE INITIAL SURGEON PRESCRIBED VITAMIN E TO TREAT THE VISUAL EVENTS. THE POSTERIOR CAPSULAR MEMBRANE WAS NOTED TO HAVE A FINE FOLD IN IT SIX MONTHS AFTER INITIAL LENS IMPLANTATION. THE SURGEON SHE SAW FOR A SECOND OPINION SUGGESTED THE LENS EXCHANGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427459 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12173912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MONARCH II "B" CARTRIDGES| DUOVISC| MONARCH IOL DELIVER SYSTEM HANDPIECE