BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2969444 · Received February 15, 2013

    Report

    Report Number
    1119421-2013-00153
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ALCON RESEARCH, LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THERE WAS NOT ENOUGH INFORMATION PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. CITATION: WINTLE R, AUSTIN M. PIGMENT DISPERSION WITH ELEVATED INTRAOCULAR PRESSURE AFTER ACRYSOF IOL IMPLANTATION IN THE CILIARY SULCUS. J CATARACT REFRACT SURG 2001; 27:642-644. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE INVESTIGATOR REPORTED THAT A PATIENT HAD A PHACOEMULSIFICATION WITH INTRAOCULAR LENS (IOL) IMPLANTATION. DURING ASPIRATION OF FINAL SOFT LENS MATTER, A LINEAR TEAR WAS MADE IN THE POSTERIOR CAPSULE WITHOUT VITREOUS LOSS. CORTICAL LENS MATTER WAS REMOVED AND AN IOL WAS IMPLANTED IN THE CILIARY SULCUS. POSTOPERATIVELY, VISUAL REHABILITATION WAS GOOD, WITH A VISUAL ACUITY OF 6/6. ONE MONTH POSTOPERATIVE, THE PATIENT PRESENTED WITH AN INTRAOCULAR PRESSURE (IOP) OF 30 MMHG AND SIGNS OF PIGMENT DISPERSION WITH 360 DEGREES OF HEAVY PIGMENTATION OF THE TRABECULAR AND IRIS TRANSILLUMINATION DEFECTS. THE EYE WAS OTHERWISE QUIET. INTRAOCULAR PRESSURE WAS CONTROLLED WITH A TOPICAL BETA-BLOCKER. AFTER 6 MONTHS OF STABLE IOP, BETA-BLOQUER THERAPY WAS DISCONTINUED WITHOUT A SUBSEQUENT INCREASE IN IOP OVER A FURTHER 18 MONTHS. THE OPTIC DISC APPEARANCE AND VISUAL FIELD REMAINED NORMAL, BUT THE UNIOCULAR HYPERPIGMENTATION OF THE TRABECULAR MESHWORK WAS STILL PRESENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67221 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON MA60BM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention