phakic intraocular lenses– clinical guidancefor panel（phakic intraocular lenses - clinical guidancefor panel）.docVIP

Phakic Intraocular Lenses Clinical Topics for Ophthalmic Devices Panel Discussion August 2, 2002 Scope The discussion topics to be included in draft standards and proposed guidance apply to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye. References ISO 11979-1 - 1999, Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary ANSI Z80.7 - 2001, American national standard for ophthalmics-intraocular lenses ISO 11979-7 – 2001, Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations ISO