AcrySof UltraSert recallZ-2287-2020 · Alcon Research LLC · initiated Apr 17, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alcon Research LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect IOL diopter
FDA root cause category: Process control
What the company is doing
On 04/17/2020, the firm sent an "Urgent: Voluntary Medical Device Removal' letter to customers via overnight mail that the firm became aware that there was a potential problem relating to the IOL of wrong sized diopter, in a pre-loaded delivery system. Should a patient be implanted with an IOL having incorrect optical power, a refractive error would result. Patients with a refractive error may experience symptoms from mild blurred vision to decreased vision, which may require additional interventions such as spectacles or surgical intervention to correct. The firm is instructing customers to: (i) Return any unused product of specified lot number (ii) The firm's Customer Service will contact customers to arrange for the return and replacement of affected Pre-loaded delivery system (iii) Fill out "Response Form" (iv) Return the "Response form" via fax or email to the firm, provided of contact information: Fax No.: 817-302-4337; E-mail: [email protected] Additionally, the firm is asking customers to: Reach out to firm's Sales Representative for any questions.
Recall details
- Recall number
- Z-2287-2020
- Status
- Terminated
- Initiated by the company
- Apr 17, 2020
- Recalling firm
- Alcon Research LLC
- Quantity
- 84 units
- Product code
- HQL
- FDA submissions
- P930014S084
- Distribution
- US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
Product description
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Code information (models, lots, serial numbers)
Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AcrySof® UltraSert® AU00T0Alcon Laboratories, Inc. · intraocular lens1 recall49 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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