PURPOSE To evaluate the visual and refractive stability and the potential long-term risks associated with ZB5M phakic intraocular lens (PIOL) implantation. METHODS A retrospective, non-randomized, cumulative clinical study was performed over 12 years in a consecutive group of 225 eyes implanted with the ZB5M PIOL. The main analyzed variables were visual and refractive outcomes (best spectacle-corrected visual acuity [BSCVA], uncorrected visual acuity [UCVA], and spherical equivalent), endothelial cell density, and postoperative complications. RESULTS Mean preoperative spherical equivalent refraction was -17.23 +/- 7.69 diopters (D) and 12 years postoperatively it was -1.80 +/- 0.80 D. Mean BSCVA at 1- and 12-year follow-up was 0.38 +/- 0.19 and 0.57 +/- 0.18, respectively (Wilcoxon test, P < .001). At 12 years postoperatively, 3.5% of eyes lost > or = 2 lines of BSCVA. An initial 10.6% reduction in endothelial cell density was noted in the first year, followed by a mean annual rate of decrease of 1.78%. The cumulative incidence of pupil ovalization was 34.7% (78 eyes), and there was no statistical correlation with endothelial cell impairment. Bilateral hypertensive uveitis was diagnosed in 3 (1.33%) eyes. CONCLUSIONS The ZB5M PIOL offers good refractive outcomes and stability in the long-term; however, endothelial cell loss increases over 12 years, requiring annual endothelial cell counts.