BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULCOFLEX ASPHERIC

    MDR report key: 3953322 · Received July 18, 2014

    Report

    Report Number
    3003563511-2014-00059
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 19, 2014
    Report Date
    July 4, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENS LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LIMITED REPORTS THE FOLLOWING INVESTIGATION FINDINGS: OUR REVIEW OF PRODUCTION RECORDS FOR THE SULCOFLEX ASPHERIC 653L IOL BATCH 072E39100 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE SULCOFLEX ASPHERIC 653L IOL (JULY 2012) WAS CARRIED OUT IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE SULCOFLEX ASPHERIC IOL BATCH (B)(4).

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS (B)(4) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A SULCOFLEX ASPHERIC 653L INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT THE DEVELOPMENT OF OPACIFICATION WAS OBSERVED ON (B)(6) 2014. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423618 SULCOFLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENS LIMITED 653L 072E39100

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention FORTAZ| INTRAVITREAL INJECTION OF SILICON OIL 5700| VANCOMYCIN