Z-2287-2020Class II

Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert...

Name: Z-2287-2020 Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert...
Creator: Alcon Research LLC
Published: 2020-04-17
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2020-04-17 / Terminated / root cause: manufacturing process

FDA source

Alcon Research LLC began a recall of 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... on 2020-04-17. FDA classified it as Class II and gives the reason as "Incorrect IOL diopter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2287-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-17
Posted: 2020-06-05
Terminated: 2021-02-05
Recalling firm: Alcon Laboratories
Product: 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.
Product code: HQL Intraocular Lens
Reason for recall: Incorrect IOL diopter
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 84 units
Distribution: US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
Product codes and lots: Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2287-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2287-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-05

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)