BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 4793486 · Received May 22, 2015

    Report

    Report Number
    1119421-2015-05440
    Event Type
    Injury
    Date Received
    May 22, 2015
    Report Date
    August 13, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE REPORT INDICATED NO SIGNIFICANT CHANGE IN TOPOGRAPHY OCCURRED, BUT IOL ROTATION WAS REQUIRED TO MAXIMIZE THE REFRACTIVE OUTCOME DESPITE APPROPRIATE IOL ALIGNMENT BASED ON PREOPERATIVE MEASUREMENTS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED BY FAX AND PHONE. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. J. LOCKWOOD, TORIC INTRAOCULAR LENS ROTATION TO OPTIMIZE REFRACTIVE OUTCOME DESPITE APPROPRIATE POSITIONING; J CATARACT REFRACT SURG APRIL 2015; 41:878-883. (B)(4).

    Description of Event or Problem · 1

    IN A CASE REPORT, THE AUTHORS PRESENTED 3 EYES OF 2 PATIENTS WHO BENEFITED FROM TORIC INTRAOCULAR LENS (IOL) ROTATION FOLLOWING IOL IMPLANT PROCEDURES DESPITE APPROPRIATE INTRAOPERATIVE POSITIONING. IN THE FIRST CASE, A DRAMATIC SHIFT IN CORNEAL TOPOGRAPHY OCCURRED AFTER SURGERY, RESULTING IN THE NEED TO ROTATE THE IOL TO MAXIMIZE THE REFRACTIVE OUTCOME. IN THE SECOND CASE (BOTH EYES), NO SIGNIFICANT CHANGE IN TOPOGRAPHY OCCURRED, BUT IOL ROTATION WAS REQUIRED TO MAXIMIZE THE REFRACTIVE OUTCOME DESPITE APPROPRIATE IOL ALIGNMENT BASED ON PREOPERATIVE MEASUREMENTS. IN BOTH CASES, THE PATIENT EXPERIENCED BLURRY VISION PRIOR TO THE IOL ROTATION PROCEDURE. FOLLOWING THE ROTATION PROCEDURE, BOTH PATIENTS WERE HAPPY WITH THE OUTCOME. THIS REPORT IS FOR THE SECOND CASE, LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336611 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention