BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 3000574 · Received March 12, 2013

    Report

    Report Number
    2648035-2013-00120
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT RETURNED. AN EMPTY BOX WAS RETURNED INDICATING THAT THE LENS WAS ''WASTED; NOT IMPLANTED''. BATCH RECORDS WERE REVIEWED AND WERE FOUND WITHIN PRODUCT SPECIFICATIONS. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALSO, THE REVIEW OF THE DOCUMENTATION FOR SLIT LAMP INSPECTION OF SILICONE LENS INSPECTION SHOWS THAT ALL THE LENSES SAMPLED HAD AN ACCEPTABLE HAZE LEVEL. NO DEVIATION OR NONCONFORMANCE WAS GENERATED. NO DISCREPANCY RELATED TO QUANTITY WAS FOUND. RAW MATERIAL RECORDS REVIEWED WERE WITHIN SPECIFICATION. IN MANUFACTURING AT THE FINAL INSPECTION PROCESS, THE LENSES ARE 100% CLEANED AND INSPECTED AT 10X MICROSCOPE MAGNIFICATION. NO ISSUES WERE REPORTED. PROCESS AND/OR MATERIAL CHANGES WERE WITHIN SPECIFICATIONS. STERILIZATION RECORDS WERE WITHIN SPECIFICATIONS. BASED ON THE MANUFACTURING INSTRUCTIONS, A 100% INSPECTION OF THE LENSES FOR HAZE LEVEL IS PERFORMED BY THE MANUFACTURING OPERATORS. NO DEVIATION DUE TO UNACCEPTABLE HAZE LEVEL WAS REPORTED IN THIS PRODUCTION ORDER. CONCLUSION: THE MANUFACTURING RECORD AND RELATED DOCUMENTS SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR ATTEMPTED TO REPLACE THE ORIGINAL INTRAOCULAR LENS (IOL) WITH ANOTHER LENS; HOWEVER, THE DOCTOR DECIDED TO USE A DIFFERENT TYPE LENS. THE DOCTOR EXPLANTED THE LENS AND IN DOING SO, ENLARGED THE INCISION. FURTHER, IT WAS INDICATED THAT THE LENS WAS AN IMPROPER FIT FOR THE PATIENT. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY WITH NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104164 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention