NIDEK CO., LTD, CMP-2022-0774, EYECEE ONE preloaded

We are writing to inform you of a Field Safety Notice for all lots of preloaded versions of EyeCee One intraocular lenses (IOLs) that are manufactured by NIDEK and distributed by Bausch + Lomb (a full list of affected products is in attachment A).
NIDEK has issued this field safety notice while it undergoes a full investigation, in collaboration with Bausch + Lomb, due to a limited number of reports of high ocular hypertension in patients who were implanted with one of these lenses. A preliminary investigation has thus far not established a link between these preloaded EyeCee One IOLs and the reports of high ocular hypertension or identified a root cause. Nidek and Bausch + Lomb are continuing to investigate this issue to definitively determine the root cause of these reports and whether a link to these products exists.