Instructions for Use
Instructions for Use
CE Mark (European Union)
UKCA Mark (UK)
Authorized Representative in the European Community
Indizen Optical Technologies S.L.U. dba IOT distributes semifinished ophthalmic lenses. These semifinished 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 IOT semifinished 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
IOT semifinished 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 semifinished lenses accordingly and in a qualified manner.
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 Camber semifinished lenses, there are marks for horizontal orientation and TOP area at the outside of the lens.
WARNINGS AND PRECAUTIONS
The IOT semifinished ophthalmic devices are not considered finished medical devices and are therefore not intended for use until after they have been further processed by a qualified laboratory. They are not intended to be used by patients or end users until further product finishing, processing and being inserted into frames upon the prescription of an eye care practitioner.
For further information or to request a physical copy of these instructions for use, please contact IOT.
LLC 3625 Del Amo Blvd. #365
Torrance, CA 90503, USA
UKRP Services Ltd
Clyde Offices 2nd Floor
48 West George Street
Glasgow G2 1BP, UK
Date modified: January 2024