Indizen Optical Technologies S.L.U. (IOT) distribui lentes oftálmicas semi-acabadas. Estas lentes semi-acabadas são compostas por uma variedade de materiais, tratamentos e desenhos. Os materiais utilizados são formados por diferentes plásticos fabricados e testados de acordo com os requisitos regulatórios aplicáveis.
INSTRUÇÕES DE USO
As lentes oftálmicas semiterminadas da IOT são adequadas para uso, após processamento posterior em laboratório, e ajudam a corrigir a visão associada à miopia, hipermetropia, astigmatismo e presbiopia. Elas são destinadas a serem usadas por pacientes sob a direção e prescrição de um profissional de saúde ocular, ou seja, um optometrista.
DIRECTRIZES DE UTILIZAÇÃO
As lentes oftálmicas semiterminadas da IOT são vendidas para laboratórios oftálmicos autorizados para processamento posterior, que inclui polimento, retificação, revestimento, etc. Cada laboratório deve seguir seus próprios procedimentos e protocolos internos para processar adequadamente as lentes semiterminadas de maneira qualificada e adequada.
INSTRUÇÕES OPERATIVAS
As lentes só devem ser usadas com outros dispositivos compatíveis, como definido na norma ISO 12870 para armações ópticas e montadas de acordo com a norma ISO 21987 (lentes de óculos montadas). Para as lentes semi-acabadas "Camber", há marcas para a orientação horizontal e superior no exterior da lente.
ADVERTÊNCIAS E PRECAUÇÕES
Os dispositivos oftálmicos semiterminados da IOT não são considerados dispositivos médicos terminados e, portanto, não se destinam a ser utilizados até que tenham sido processados adequadamente por um laboratório qualificado. Não se destinam a ser utilizados por pacientes ou utilizadores finais até que se completem os processos de acabamento do produto e se insiram em armações de acordo com a prescrição de um profissional de saúde ocular.
Para obter mais informações ou solicitar uma cópia física destas instruções de uso, entre em contato com a IOT.
Fabricante
Advanced Photochromics
LLC 3625 Del Amo Blvd. #365
Torrance, CA 90503, USA
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