Aaren Scientific, Incorporated recalls Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24…

Recall date

February 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1309-2015

FDA classification

Class II

Brand / firm

Aaren Scientific, Incorporated

Sold / distributed

Distributed in the states of OK, KS, FL, and AL.

Why it was recalled

Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.