BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 9687300 · Received February 10, 2020

    Report

    Report Number
    9612169-2020-00048
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    July 18, 2019
    Report Date
    June 4, 2020
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED DAMAGE COULD NOT BE CONFIRMED. THE IOL WAS RETURNED ADHERED TO A GAUZE TAPE INSIDE A ZIP LOCK BAG. SOLUTION IS DRIED ON THE IOL. THE OPTIC IS TORN/SPLIT-CUT DIVIDING THE IOL IN TWO(2) AND SCRATCHED/MARKED-REJECTABLE. OPTICAL POWER & RESOLUTION COULD NOT BE VERIFIED DUE TO THE EXTENSIVE OPTIC DAMAGE. THE ROOT CAUSE FOR THE REPORTED COMPLAINT APPEARS TO BE A COINCIDENTAL EVENT THAT WAS UNRELATED TO THE PRODUCT AS USER FACILITY REPORTED THAT ACCORDING TO THE SURGEON, MILD CONTRACTION OF CAPSULE BAG CAUSED IOL TO TILT. BASED ON THIS INFORMATION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THAT APPROXIMATELY 4 MONTHS FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRED VISION. IN THE SURGEON'S OPINION CORNEAL EDEMA, MILD TILT OF THE IOL IN THE BACK, LIKELY AS HEALING FROM THE CATARACT SURGERY, MILD CONTRACTION OF THE CAPSULE BAG CAUSED THE IOL TO TILT IS WHAT CAUSE OR CONTRIBUTED TO THE EVENT. SLIT LAMP EXAM NOTED CORNEAL ENDOTHELIAL PIGMENT AND EDEMA SECONDARY. ANTERIOR CHAMBER DEEP AND QUIET. IRIS PIGMENT ON IRIS AND TRANSILLUMINATION BETWEEN 10 O'CLOCK & 1 O'CLOCK. LENS: POSTERIOR CHAMBER IOL TILTED & DISLOCATED IOL ABOVE THE BAG. THE IOL WAS EXCHANGED FOR ANOTHER MANUFACTURERS LENS MODEL WITH A 2 DIOPTER DIFFERENCE OF POWER. THE PATIENT'S ISSUES HAVE RESOLVED WITH THE IOL REMOVAL AND THE REPLACEMENT IOL PLACED IN SULCUS. THE PATIENT IS COMPROMISED IN CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150660 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21227407

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention