The American National Standards Institute Z80 Accredited Standards Committee for Ophthalmic Optics has announced a new standard for toric IOLs.
Alexandria, VA-The American National Standards Institute (ANSI) Z80 Accredited Standards Committee for Ophthalmic Optics has announced a new standard for toric IOLs.
The standard applies to any monofocal IOL designed primarily to reduce astigmatism to correct aphakia or modify the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia.
The new ANSI Z80.30 standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for IOLs, according to the organization. Specifically, it addresses the requirements and test methods for IOLs used to correct inherent residual astigmatism in the aphakic eye.
“After the crystalline lens of the eye has been removed, toric lens implants can modify the residual refractive state in such an eye . . . to reduce preoperatively or intraoperatively measured astigmatic refractive error that generally arises from the cornea,” said Carl Tubbs, MD, chairman of the ANSI Z80 Subcommittee on Medical Ophthalmic Devices. “This standard will help to ensure that patients receive the best IOLs possible.”
The new ANSI Z80.30 standard for toric IOLs can be purchased at the ANSI Web store, http://webstore.ansi.org/.