FDA-Device2015-04-01Class II
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 remo
Aaren Scientific, Incorporated
Hazard
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Sold states
Distributed in the states of OK, KS, FL, and AL.
Affected count
28 units
Manufactured in
4290 E Brickell St Ste A, Ontario, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1309-2015Don't want to check this manually?
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