Recall Z-1309-2015— Aaren Scientific, Incorporated
Class II · Terminated
Class II FDA medical device recall by Aaren Scientific, Incorporated, initiated 2015-02-13, terminated 2015-06-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements..
- Recalling firm
- Aaren Scientific, Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-13
- Terminated
- 2015-06-29
- Firm location
- Ontario, CA, United States
Product description
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.
Reason for recall
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Data sourced from openFDA. This site is unofficial and independent of the FDA.