ANSI Z80.30:2018 pdf free download – Toric Intraocular Lenses
7.3 Biological test requirements
The requirements in 7.3 of ANSI Z80.7 shall apply, with the following additional requirements: Manufacturers of new toric IOL materials shall include in their risk analysis an assessment of the potential for material changes such as calcification following implantation. The risk analysis should consider the history of clinical use of the material, and tests to assess the long-term stability of the material in an in-vivo environment. A monocular implantation test to assess the stability of the material shall be performed as outlined in ISO 11979-5. After the light microscopy evaluation of the explanted toric IOLs from the ocular implantation test (ANSI Z80.7, Annex C), half of the samples shall be thoroughly cleaned (if the optical surfaces can be cleaned without being damaged) and then assessed for changes in optical properties in accordance with the requirements in clause 5 of ANSI Z80.30. The other half of the samples shall then be evaluated by SEM/ EDX, where feasible, for surface changes. NOTE: The test or control material used for the ocular implantation test (ANSI Z80.7, Annex C) may be a representative sample of the toric IOL that has gone through the same fabrication methods as the device to be marketed, has a mass at least equivalent to the finished toric IOL, and has a size and shape that would allow the required post-retrieval evaluations to be performed, if its use can be justified.
10.2 Requirements
The axis misalignment, defined as the absolute difference between intended IOL axis of orientation (namely ink marks or other methods of marking the eye correlated with landmarks such as blood vessels/iris features assessed during or immediately at the end of surgery) and all subsequent forms beginning at Form 4 as measured by a direct/photographic based method, , shall be less than 10 o in 90% of the cases and less than 20 o in 95% of the cases. In addition, the clinical investigation plan shall provide evidence of the stability of the toric IOL axis. Stability of the toric IOL axis shall be achieved if 90% of the toric IOLs in the treated eyes rotate less than or equal to five degrees between the final two consecutive visits. The residual manifest cylinder as measured by manifest refraction at Form 4 or later for the lowest toric IOL power cylinder correction shall be statistically lower than the residual manifest cylinder for the non- toric control IOL for the randomized investigation with both groups matched for preoperative corneal cylinder. Subjects that have a secondary surgery that is targeted to correct for postoperative toric IOL rotation shall have their clinical results prior to that surgical intervention carried forward as the final results for that subject. In cases where axis misalignment measured at follow up visits after a secondary surgical intervention (SSI) is greater than the axis misalignment prior to SSI, the greater misalignment error shall be considered final.