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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.
Recalled April 1, 2015 · FDA recall Z-1309-2015 · Aaren Scientific, Incorporated
Hazard
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements. · FDA Class II
Units
28 units
Sold at
Distributed in the states of OK, KS, FL, and AL.
Description
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Product
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.
Manufacturer(s)
Aaren Scientific, Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →