BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3940261 · Received June 19, 2014

    Report

    Report Number
    9612169-2014-00071
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT APPEARS TO BE A COINCIDENTAL EVENT THAT WAS NOT RELATED TO THE LENS AS PER OPHTHALMOLOGIST (NOT THE ONE WHO IMPLANTED THIS LENS IN SUBJECT, BUT ANOTHER DOCTOR WHO WILL BE IMPLANTING A LENS IN ANOTHER EYE). THIS DOCTOR SAID THAT IT WAS NOT THE LENS THAT CAUSED THIS DISORDER BUT CLOUDED CAPSULAR BAG (POSTERIOR CAPSULAR OPACIFICATION) BASED ON THIS INFO, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED A DECREASE IN RIGHT EYE VISUAL ACUITY SEVERAL MONTHS AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE CONSUMER NOTICED THE EVENT WHEN READING, THE LETTERS WERE BLURRED, AND FELT PAIN IN THE EYE. THE CONSUMER INDICATED THIS EVENT DID NOT SIGNIFICANTLY AFFECT HER DAILY ACTIVITIES. ADDITIONAL INFO WAS PROVIDED BY THE CONSUMER. SHE VISITED ANOTHER OPHTHALMIC SURGEON WHO INDICATED THAT THESE EVENTS WERE DUE TO A CLOUDED CAPSULAR BAG. A LASER TREATMENT WAS SCHEDULED FOR (B)(6) 2014. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359478 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21082676

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other