CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
Alcon AcrySof IQ IOL with Ultrasert Delivery System recalled
Alcon Research is recalling Alcon AcrySof IQ IOL with Ultrasert Delivery System. The recall was initiated on 28 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2708-2016
- FDA event ID
- 74824
- Recalling firm
- Alcon Research, Fort Worth, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jul 2016
- FDA classified
- 1 Sep 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 28 Jul 2016 | Recall initiated by company | |
| 1 Sep 2016 | Classified by FDA | +35 days |
| 7 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
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 ***
Questions about this recall
Is Alcon AcrySof IQ IOL with Ultrasert Delivery System recalled?
Yes. Alcon Research recalled Alcon AcrySof IQ IOL with Ultrasert Delivery System on 28 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2708-2016.
Why was it 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
Which lots are affected?
Lot numbers: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028
Where was it sold?
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 ***
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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