Annex D (informative) Labeling D.1 This provides recommendations for labeling of EDF IOLs in addition to the requirements stated in clause 11. D.2 Information to be found on the outer container applicable, the following items should be provided on the outer lens container: Name and address of manufacturer Trade name number Diopter Lot/serial number Overall diameter and optic body diameter (minimum and maximum if non-symmetric) Drawing/diagram depicting configuration of the lens Anatomical placement Expiration date Use” statement or symbol “Single statement or symbol “Sterile” Method of sterilization Storage conditions D.3 Labeling for inner container and/or pouch The inner container and/or pouch should provide the following information: Name of manufacturer number Diopter Lot/serial number Overall diameter and optic body diameter (minimum and maximum if non-symmetric) The following statements: not reuse,” not resterilize” “Sterile,” “Do “Do D.4 Physician package insert The package insert for the implanting physician should include the following information: Prescription device statement: Federal (USA) law restricts this device to sale by or on “Caution: the order of a physician.” Indications for use Contraindications Warnings Precautions Adverse events experienced during the clinical investigation
Annex D (informative) Labeling D.1 This provides recommendations for labeling of EDF IOLs in addition to the requirements stated in clause 11. D.2 Information to be found on the outer container applicable, the following items should be provided on the outer lens container: Name and address of manufacturer Trade name number Diopter Lot/serial number Overall diameter and optic body diameter (minimum and maximum if non-symmetric) Drawing/diagram depicting configuration of the lens Anatomical placement Expiration date “Single Use” statement or symbol “Sterile” statement or symbol Method of sterilization Storage conditions D.3 Labeling for inner container and/or pouch The inner container and/or pouch should provide the following information: Name of manufacturer number Diopter Lot/serial number Overall diameter and optic body diameter (minimum and maximum if non-symmetric) The following statements: “Sterile,” “Do not reuse,” “Do not resterilize” D.4 Physician package insert The package insert for the implanting physician should include the following information: Prescription device statement: “Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.” Indications for use Contraindications Warnings Precautions Adverse events experienced during the clinical investigation
Draft-ANSI-Z80-35-EDF-Rev-05.docx