Alcon AcrySof IQ Intraocular Lens Recall Due to Delivery System Defect
Alcon is recalling specific lots of AcrySof IQ intraocular lenses because the ULTRASERT delivery system may cause the lens to become lodged during implantation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect in a medical device that could cause the lens to become lodged during surgery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Alcon Research, Ltd. is recalling 371 units of the Alcon AcrySof IQ Intraocular Lens (IOL) with the ULTRASERT Delivery System. The recall affects specific lots: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, and 12409028. The AcrySof IQ IOL is an acrylic foldable single-piece posterior chamber lens used to replace the human crystalline lens in adult patients following cataract surgery.
The recall is due to an inferior surface characteristic in the ULTRASERT Delivery System from certain lots. This defect could result in the intraocular lens becoming lodged in the delivery system during the implantation process. The affected product was distributed to consignees in Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom, and United Arab Emirates. The source text explicitly states that while the product is available in the US, these specific lots were not distributed to US consignees.
Healthcare providers and patients who have received or are scheduled to receive these specific lots of the Alcon AcrySof IQ IOL should contact Alcon Research, Ltd. for further instructions on how to proceed with the recall and potential replacement of the device.
The recalled product
- 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 fol
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 371
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot numbers: 12407022
- 12407085
- 12407087
- 12409013
- 12409024
- 12409026
- 12409028
Distribution
Distribution scope not specified by the agency.
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