Device product
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.
Z-2708-2016
Product summary
- Event
- Event 74824
- Status
- Terminated
- Classification
- Class II
- Quantity
- 371 units
- Official record key
device-enforcement:Z-2708-2016
Official wording
Reason: The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
Code information: Lot numbers: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028
Distribution pattern: 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 ***
Derived failure modes
-
Unknown
The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System