The most common adverse event was dry eye, which occurred in 13 patients in the first eye (8.7%), and 11 patients in the second eye (7.4%). One patient (0.7%) reported 2 serious adverse events of blurred vision and IOL extraction that were related to the study device.
The most common, non-serious adverse events related to the PanOptix IOL were halos (first eye, n=4 [2.7%], second eye, n=3 [2.0%]), and glare (first eye, n=2 [1.3%], second eye, n=2 [1.4%]). Seven patients (5%) had non-fatal serious adverse events, and 3 deaths were reported. The causes of death were myocardial infarction, acute myocardial infarction, and multi-organ failure–all unrelated to the study device or the study procedures.
The researchers concluded the early results from this study show good visual performance (visual acuity better or equal to 20/25) of the AcrySof IQ PanOptix IOL across the whole range of defocus. At the 6-month visit, the binocular defocus curve for the IOL demonstrated approximate visual acuity of 20/25 or better from near (40 cm) through intermediate (60 cm) to distance. No unexpected adverse events were reported.