BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6020064 · Received October 12, 2016

    Report

    Report Number
    9612169-2016-00137
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 12, 2016
    Report Date
    January 3, 2017
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS NOT OBSERVED. BOTH HAPTICS ARE INTACT. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS: IOL RETURNED IN TWO(2) SEGMENTS IN THE IOL CASE. THE IOL SEGMENTS ARE IMMERSED IN SOLUTION. BOTH HAPTICS ARE INTACT. THE OPTIC IS TORN/SPLIT/CUT DIVIDING THE IOL IN TWO(2) AND SCRATCHED/MARKED REJECTABLE. ADDITIONAL INFORMATION: FILE REFERENCES USE OF TWO VISCOELASTICS, ONE FROM ANOTHER MANUFACTURER USED TOGETHER WITH A CARTRIDGE . NEITHER OF THE MENTIONED VISCOELASTICS ARE QUALIFIED FOR USE WITH THE MODEL USED WHEN USING THE SPECIFIED CARTRIDGE. BASED ON THE PRODUCT EVALUATION, THE REPORTED DESCRIPTION OF "PERIPHERAL CRACK OF HAPTIC, CAPSULAR RUPTURE, REMOVAL" DOES NOT MATCH THE PRODUCT EVALUATION FINDINGS. THE IOL WAS RETURNED WITH BOTH HAPTICS INTACT. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE MOST LIKELY ROOT CAUSE IS FAILURE TO FOLLOW DFU, AS THE SURGEON STATES THE USE OF NOT QUALIFIED VISCOELASTIC WHICH MAY HAVE CAUSED DELIVERY ISSUES/CAPSULAR RUPTURE. DUE TO DIFFERING MATERIAL PROPERTIES, THE USE OF A NON-QUALIFIED VISCOELASTIC MAY RESULT IN DELIVERY ISSUES AND/OR DAMAGE. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THROUGH A PRODUCT RETURN THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS REMOVED DUE TO A CAPSULAR TEAR. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON THAT WHEN INSERTING THE LENS, HE NOTICED THERE WAS A PERIPHERAL CRACK IN THE HAPTIC. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH A NEW ONE. AN ENLARGEMENT OF THE INCISION WAS NECESSARY. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671283 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. SN6AT4 21117818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MONARCH III D IOL CARTRIDGE| UNKNOWN VISCOELASTIC: EITHER VISTHESIA OR PROVISC