BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2842147 · Received November 13, 2012

    Report

    Report Number
    1119421-2012-01386
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADD'L INFO WAS REQUESTED AND REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT ON THE FIRST POSTOPERATIVE DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SURFACE CLOUDING OF THE LENS WAS OBSERVED. THE PT REPORTED POOR VISION AND HER VISUAL ACUITY EXAMINATION COULD NOT BE PERFORMED DUE TO POOR VISION. ON THE SECOND POSTOPERATIVE DAY, THE CLOUDING WAS NOT RECOVERED AND NO VISUAL ACUITY EXAMINATION COULD BE PERFORMED. THE PT WAS TAKEN BACK TO SURGERY ON THE FIFTH POSTOPERATIVE DAY. THE SURGEON HAD PLANNED TO EXCHANGED THE LENS. THE SURGEON PERFORMED A SURFACE POLISH AND WHEN THE LENS WAS TOUCHED WITH THE IRRIGATION/ASPIRATION (I/A) TIP, THE SURGEON NOTED THE IOL CLOUDING WAS ABLE TO BE REMOVED. THE FIRST DAY FOLLOWING THIS PROCEDURE, THE PT REPORTED THE SUBSTANCE LIKE AN "ICE BALL" IN THE VISUAL FIELD WAS GONE BUT THERE WERE STILL SMALL SUBSTANCES LIKE GRAINS. BY THE SECOND POST-POLISHING DAY, THE PT VISUAL ACUITY HAD RECOVERED TO 0.7 (20/32) AND THE SURFACE CLOUDING WAS NOTED TO HAVE DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention