BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3682745 · Received March 5, 2014

    Report

    Report Number
    1119421-2014-00160
    Event Type
    Injury
    Date Received
    March 5, 2014
    Date of Event
    January 1, 2013
    Report Date
    February 5, 2014
    Manufacturer
    ALCON RESEARCH, LTD
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 TOT HE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. LIT CIT: KOSKER M., SUNGUR G., CELIK T., UNLU N., SIMSEK S., PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH ANTERIOR UVEITIS J CATARACT REFRACT SURG 2013; 39:1002-1007. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, THE AUTHORS REPORTED SEVEN CASES OF POSTERIOR CAPSULAR OPACIFICATION (PCO) AFTER PHACOEMULSIFICATION WITH INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENTS WITH ANTERIOR UVEITIS. TWO OF THESE SEVEN CASES WERE TREATED WITH YAG LASER CAPSULOTOMY BECAUSE THE PCO CAUSED LOW CORRECTED DISTANCE VISUAL ACUITY (CDVA) AND GLARE. THE LITERATURE ARTICLE ALSO INFORMED THAT ALL THE PATIENTS WITH A HISTORY OF ANTERIOR UVEITIS. TWO OF THESE SEVEN CASES WERE TREATED WITH YAG LASER CAPSULOTOMY BECAUSE THE PCO CAUSED LOW CORRECTED DISTANCE VISUAL ACUITY (CDVA) AND GLARE. THE LITERATURE ARTICLE ALSO INFORMED THAT ALL THE PATIENTS WITH A HISTORY OF ANTERIOR UVEITIS AND CATARACT HAVING PHACOEMULSIFICATION WITH POSTERIOR CAPSULE (PC) IOL IMPLANTATION HAD EXCELLENT VISUAL RESULTS WITH A RELATIVELY LOW COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132643 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD MA60BM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R