BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 3230471 · Received July 16, 2013

    Report

    Report Number
    2648035-2013-00291
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MANUFACTURING DATE CORRECTED TO 05/13/2013. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS INSPECTED AT THE MANUFACTURING SITE UNDER 10X MICROSCOPE MAGNIFICATION. VISUAL INSPECTION REVEALED SURFACE RESIDUE ADHERING TO BOTH SIDES OF THE OPTIC BODY WITH EVIDENCE OF BLOOD, DEBRIS AND OPTHALMIC VISCOSURGICAL DEVICE (OVD) COMPATIBLE WITH HANDLING, SUCH AS DURING THE IMPLANT AND EXPLANT PROCESS. THE LENS HAD ONE DISTORTED HAPTIC AND IOL WAS TORN NEAR IOL OPTIC/HAPTIC JUNCTION. THE COMPLAINT FOR HAPTIC/ OPTIC TEAR WAS VERIFIED IN THE RETURNED SAMPLE. BASED ON THE MANUFACTURING RECORD REVIEW, ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE WITHIN SPECIFICATIONS AND IN COMPLIANCE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS IMPLANTING A MODEL ZCB00V INTRAOCULAR LENS (IOL) FOR THE FIRST TIME. IT WAS STATED THAT IT TURNED AND WAS INSERTED IN THE PATIENT'S EYE. IT WAS STATED THAT THE HAPTICS OF THE LENS HAD BEEN BROKEN OFF DURING THE PROCEDURE. THE DOCTOR THEN REMOVED THE LENS WITHIN THE SAME PROCEDURE AND IMPLANTED ANOTHER LENS OF THE SAME MODEL WITHOUT A PROBLEM. IT WAS STATED THAT THE LENS WAS HALF-CUT WHEN REMOVED FROM THE PATIENT'S EYE AND THAT THE INCISION WAS A BIT ENLARGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO OTHER INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329114 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention