Survey of the optical quality of intraocular lens implants.
Intraocular lenses (IOLs) from 15 U.S. firms were tested for conformance to the requirements of the American National Standards Institute Z80.7 standard for IOLs. A total of 162 IOLs were tested for resolution, astigmatism, and accuracy of labeled power. Average resolving power was 78% of the diffraction limit, much better than the ANSI minimum requirement which is typically equivalent to 30% of the diffraction limit. This suggests that the ANSI Z80.7 requirement could be significantly tightened with little effect on current production practices. Only one IOL exhibited astigmatism in excess of 0.25 diopter. Differences between measured and labeled power in excess of 0.50 diopter were found in 22 lenses, indicating that accuracy of refractive power may be the most commonly missed optical requirement of the standard.
Grossman
L W
LW
Office of Science and Technology, Food and Drug Administration, Rockville, Maryland 20857.
Igel
D A
DA
Faaland
R W
RW
D004867:Equipment Design / Q000592:standards; D007910:Lenses, Intraocular / Q000592:standards*; D008768:Methylmethacrylates; D055095:Optics and Photonics; D011786:Quality Control
D008768:Methylmethacrylates