Recall Z-2708-2016 ยท HQL Intraocular Lens
Alcon Research, Ltd.
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
| Date | Sep 1, 2016 (initiated Jul 28, 2016) |
| Status | Terminated |
| 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 |
| Root cause | Process control |
| Action | Alcon Research sent an Urgent Field Safety Notice letter dated July 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check their inventory and segregate any product being recalled. Customers were asked to complete and return the Field Safety Notice Response Form. For questions or concerns contact Alcon. |
| Quantity | 371 units |
| Distribution | 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 a |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.