Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage:… — Class II medical device recall Z-2708-2016
Terminated recall by Alcon Research, Ltd., reported 2016-09-07. The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in t
| Recall number | Z-2708-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2016-07-28 |
| Classified | 2016-09-01 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2017-06-07 |
| Countries outside the US | AE, BE, BG, CH, DE, ES, FI, FR, GB, HR, HU, IE, IT, LT, MY, NL, NO, PL, PT, QA, RO, SE, SI, TH |
| Quantity | 371 units |
| Lot numbers | 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028 |
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.
Reason for recall
The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2708-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.