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ZYOPTIX Technolas 217z brief statement
All promotion and advertising for these devices must include the following in information on indications, risks and benefits:
- Approval of the premarket approval application supplement is for the TECHNOLAS 217z® Zyoptix System for Personalized Vision Correction to perform wavefront guided LASIK treatments in patients 21 years of age or older for the reduction or elimination of myopia up to 7.00 D sphere with up to 3.00 D of astigmatism and MRSE < 7.50 D at the spectacle plane; and in patients with documented stability of refraction for the 12 months prior to the date of the pre operative examination, as demonstrated by a change of less than or equal to 0. 5 0 D.
- Wavefront guided LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), conventional LASIK, and other refractive surgeries.
- Approval of the application is based on a clinical trial of 340 eyes (117 spherical eyes and 223 spherocylindrical eyes). All treated eyes were available for analysis of safety at 3 months, and all eyes were followed for 6 months. Accountability at 3 and 6 months was 100.0%. All 340 eyes were evaluated for effectiveness with 100.0% accountability at both 3 and 6 months.
- The analysis of data from 340 total eyes treated and based on refractive data at 6 month follow up examination, found that 99.4 % (338/340) were corrected to 20/40 or better and 91.5 % (311/340) were corrected to 20/20 or better visual acuity without spectacles or contact tenses.
- The study showed that at the 6 month stability time point: there was a loss of > 2 lines of best corrected vision that can be obtained with spectacles in 1/223 astigmatic myopia eyes and in 1/117 spherical myopia eyes; there were no eyes with astigmatic or spherical myopia with best spectacle corrected visual acuity (BSCVA) worse than 20/25 (if 20/20 or better preoperatively). During the course of study, no eye lost > 2 lines of BSCVA and no eye had a BSCVA worse than 20/40.
- The clinical trials showed that the following adverse events occurred in at least 1% of the 340 eyes at any interval up to 6 months post treatment: debris in the interface (5.3% at I month; 2.4% at 3 months; and 1.2% at 6 months).
The following subjective patient adverse events rated "significantly worse" occurred in at least 1% of 340 eyes in the effectiveness cohort at 6 months post treatment: Fluctuation of vision (4.2%); blurring of vision (3.8%); glare (3.2%); halos (2.6%); dryness and double vision (2.4% each); headache, redness, and night driving difficulty (1.2% each).
- The safety and effectiveness of wavefront guided LASIK surgery has ONLY been established with an optical zone size between 6.0 mm and 7.0 mm with a constant blend zone of .875 mm.
- Long term risks of wavefront guided LASIK for myopia and myopic astigmatism beyond 6 months have not been studied.
- The safety and effectiveness of the TECHNOLAS 217z® Zyoptix System have NOT been established for wavefront guided surgery in patients whose Wavefront measured pupil size is less than 6.00 mm or greater than 7.00 mm; for treatments greater than 7.00 D spherical myopia, or greater than 3.00 D cylinder, or greater than 7.50 D MRSE.
- Although the Zywave® Wavefront System measures the refractive error and wavefront aberrations of the human eyes, including myopia, hyperopia, astigmatism, coma, spherical aberration, trefoil, and other higher order aberrations through fifth order, in the clinical study for this PMA, the average higher order aberration did not decrease after Zyoptix Personalized Vision Correction.
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