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.
FDA device recall Z-1309-2015 · posted 2015-03-20 · Terminated
Recall details
- Recalling firm
- Aaren Scientific, Incorporated
- Reason for recall
- Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
- Action taken
- 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 mark.scheib@zeiss.com with any questions or comments.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- 28 units
- Distribution
- Distributed in the states of OK, KS, FL, and AL.
- Date initiated
- 2015-02-13
- Date posted
- 2015-03-20
- Date terminated
- 2015-06-29
- Location
- Ontario, CA
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