Medical Device
CE Mark (Europe)
UKCA Mark for UK
Authorized Representative in the European Community
PRODUCT DESCRIPTION
Younger Mfg. Co. dba Younger Optics manufacture ophthalmic lenses. These lenses are made up of a variety of materials, treatments and designs. The materials used are from a variety of different plastics manufactured and tested according to applicable regulatory requirements.
INDICATIONS FOR USE
The Younger Optics ophthalmic lenses are indicated for use, after further laboratory processing, to assist with correcting vision associated with nearsightedness, farsightedness, astigmatism and presbyopia. They are intended to be used by patients under the direction and prescription of an eye care practitioner i.e. optometrist.
DIRECTIONS FOR USE
Younger Optics ophthalmic lenses are sold to qualified ophthalmic laboratories for further processing which includes surfacing, grinding, polishing, coating, etc. Each lab should follow their own internal procedures and protocols for adequately processing semi-finished lenses accordingly and in a qualified manner.
OPERATING INSTRUCTIONS
The lenses should only be used with other compliant devices such as ISO 12870 for optical frames and assembled in accordance with ISO 21987 (mounted spectacle lenses).
For polarizing lenses the intended horizontal orientation is parallel, for single vision lenses, to the line joining the notches and for bifocal (FT) lenses, to the straight line at the top of the segment.
For further information or to request a physical copy of these instructions for use, please contact Younger Optics.
UKRP Services Ltd
Clyde Offices, 2nd Floor
48 West George Street
Glasgow G2 1BP
UK