PMA P030028. Phakic IOL for the correction of Myopia. Goals of This Panel Meeting. Assess Evaluate Identify. Assess. Risks Benefits. Risks. Operative: Improper Enclavation – 2 nd surgical procedures Other as in cataract surgery
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for the correction of Myopia
Thresholds of critical inclusion criteria to minimize risks
Inclusion criteria specify ≥2000 as the lower limit for preop ECC
The Artisan™ Lens is indicated for
the reduction or elimination of myopia in
adults with myopia > -5 to < –20 D with
less than 2D of astigmatism at the
spectacle plane in patients with stable
Do the endothelial cell data presented
above by overall analysis, stratified
by anterior chamber depth and the
extrapolations over time provide
reasonable assurance of safety of the
Artisan myopia lens?
Do the data presented in the PMA
provide reasonable assurance of safety?
The proposed statement of indications reads:
“The reduction or elimination of myopia in
adults with myopia > -5 to < –20 D with less
than 2D of astigmatism at the spectacle plane;
Patients with documented stability of
refraction for the prior 6 months, as demon-
strated by a spherical equivalent change of
Does the panel recommend any
modifications to the proposed statement
of indications with respect to:
a). minimum anterior chamber depth (ACD’s of <3.2 mm were excluded in the study),
b). maximum pupil size (the 2 models of
Artisan are intended for patients with
pupil sizes up to 5.0 mm and up to 6.0
c). minimum preoperative endothelial cell
The outcomes of ECC changes reported
in the background data for Question #1
above should be referenced if the panel
wishes to recommend an acceptable minimum
endothelial cell density to qualify a patient.
Do the panel members have any
additional labeling recommendations?