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.
Recall
- Recall Number
- Z-1309-2015
- Event Number
- 70557
- Firm
- Aaren Scientific, Incorporated
- FEI Number
- 3013202565
- Product Code
- HQL
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- February 13, 2015
- Posted
- March 20, 2015
- Terminated
- June 29, 2015
- Address
- 4290 E Brickell St, Ste A, Ontario, CA, 91761-1569
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.
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
A customer notification letter dated 2/13/15 was sent to all customers who received the Intraocular Lens model EC-3 PAL. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to confirm receipt of the recall letter and to contact Mark Scheib at (909) 906-5119 or via email at [email protected] with any questions or comments.
Distributed in the states of OK, KS, FL, and AL.
28 units