Recall record at a glance
| Official record | Z-2708-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Alcon Research, Ltd. |
| Report date | Sep 7, 2016 |
| Recall initiation date | Jul 28, 2016 |
| Quantity | 371 units |
| Location | Fort Worth, TX, United States |
Official product description
Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.
Why the product was recalled
The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
Distribution information
Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is available in the US, these lots were not distributed to US consignees ***
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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