Recall record at a glance
| Official record | Z-1309-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Aaren Scientific, Inc. |
| Report date | Apr 1, 2015 |
| Recall initiation date | Feb 13, 2015 |
| Quantity | 28 units |
| Location | Ontario, CA, United States |
Official 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.
Why the product was recalled
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Distribution information
Distributed in the states of OK, KS, FL, and AL.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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