BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2758516 · Received September 23, 2012

    Report

    Report Number
    1119421-2012-01199
    Event Type
    Injury
    Date Received
    September 23, 2012
    Date of Event
    January 1, 2012
    Report Date
    August 23, 2012
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION AND DETERMINE A ROOT CAUSE. CITATION: BONNIE A. HENDERSON, E. BO YANG. INTRAOCULAR LENS EXPLANTATION TECHNIQUE FOR ONE-PIECE ACRYLIC LENSES. JOURNAL OF REFRACTIVE SURGERY (2012) 28:499-502. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, A SURGEON PRESENTED TWO CASES OF INTRAOCULAR LENS (IOL) EXCHANGE USING A TECHNIQUE THAT DOES NOT REQUIRE CUTTING OR FOLDING OF THE LENS, OR ENLARGEMENT OF THE ORIGINAL WOUND. THE FIRST PATIENT HAD THE IOL EXCHANGED DUE TO "POOR SATISFACTION" WITH THE LENS. THE SECOND PATIENT HAD THE IOL EXCHANGED DUE TO LENS DISLOCATION. BOTH PATIENTS UNDERWENT IOL REMOVAL USING THE DESCRIBED TECHNIQUE AND IMPLANTATION OF A THREE-PIECE IOL IN THE SULCUS. POSTOPERATIVELY, BOTH PATIENTS PRESENTED WITH A DECREASE IN CORNEAL CELL DENSITY. THERE ARE TWO MEDICAL DEVICES REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60D3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention