BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4995206 · Received August 12, 2015

    Report

    Report Number
    9612169-2015-00572
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    September 27, 2000
    Report Date
    November 4, 2015
    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
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RESULTS FROM THE PRODUCT HISTORY RECORD AND BATCH HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE LENS WAS RETURNED IN A SPECIMEN CONTAINER FILLED WITH A CLEAR UNKNOWN LIQUID. ONE HAPTIC WAS BROKEN/TORN AND NOT RETURNED. THE OPTIC WAS TORN/SPLIT/CRACKED AND SCRATCHED/MARKED-REJECTABLE. THE OPTIC HAD ADDITIONAL DAMAGE THAT GAVE THE APPEARANCE OF BLACKISH MICRO-CRACKS. NO OPACIFICATION WAS OBSERVED ON THE LENS; HOWEVER, DURING INVESTIGATION OF THE RETURNED SAMPLE, DAMAGE (BLACKISH MICRO-CRACKS) WAS OBSERVED TO THE OPTIC WHICH MAY HAVE BEEN INTERPRETED AS THE REPORTED COMPLAINT. THIS TYPE OF DAMAGE HAS BEEN SEEN IN THE PAST AND IS TYPICAL OF THE DAMAGE CAUSED BY YAG LASER CONDUCTED POST IMPLANTATION. WHILE IT IS UNABLE TO DETERMINE THE ORIGIN OF THIS DAMAGE, IT CAN BE CONCLUDED THAT IT WAS NOT PROBABLY MANUFACTURING RELATED. BASED ON THESE INVESTIGATION FINDINGS, IT IS UNABLE TO VERIFY IF THE LENS CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE IS IN TRANSIT TO THE MANUFACTURING SITE FOR INVESTIGATION. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY THE PATIENT EXPERIENCED A LENS OPACIFICATION. THE IOL WAS EXPLANTED AND AN IRIDECTOMY AND VITRECTOMY WERE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE TO DATE. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS PATIENT. THIS REPORT IS FOR PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531849 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21000604

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R VISCOAT