BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 7449713 · Received April 22, 2018

    Report

    Report Number
    3011852734-2018-00055
    Event Type
    Malfunction
    Date Received
    April 22, 2018
    Report Date
    June 13, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531710
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 04/23/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED IN ITS ORIGINAL PACKAGING. THE LENS WAS FOUND OUTSIDE THE LENS INSERT. VISUAL INSPECTION WITH THE UNAIDED EYES SHOWS THE PRODUCT IS CUT IN HALF. THE PRODUCT WAS INSPECTED BY A QUALIFIED INSPECTOR USING A 12X MAGNIFICATION, SHOWS NO ABNORMALITY FOUND ON THE PARTS. THE REPORTED COMPLAINT WAS NOT CONFIRMED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. A SEARCH REVEALED THAT NO OTHER COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS DAMAGED WHEN INJECTING IT INTO THE EYE. THE IOL DID NOT GLIDE VERY WELL IN THE UNFOLDER AND THE PLUNGER PUT A DENT ON THE LENS. THE PHYSICIAN CUT THE LENS IN HALF WITH MICROSURGICAL TECHNOLOGY (MST) BLADE AND REMOVED IT WITHOUT ANY ISSUES. A REPLACEMENT LENS WAS IMPLANTED AND THERE WAS NO PATIENT COMPLICATION OR INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292384 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531710

    Patients

    Seq Age Sex Outcome Treatment
    1