FDA Device Recall Z-2287-2020: Alcon Research LLC Aspex Facility

Recall Parameters & Description

Normalized public record details for FDA recall code Z-2287-2020.

Recall Res Number

Z-2287-2020

Recalling Firm / Manufacturer

Alcon Research LLC Aspex Facility

FEI Number

1610287

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2020-04-17

Date Posted

N/A

Date Terminated

2021-02-05

Product Code

HQL

Event Number

85563

Product Quantity

84 units

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.

Reason for Recall Incorrect IOL diopter

Action Details 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: Market.Actions@alcon.com Additionally, the firm is asking customers to: Reach out to firm's Sales Representative for any questions.

Distribution Pattern US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.

Code Information / Serial Numbers Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1

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Medical Device Recall: Z-2287-2020

Recall Parameters & Description

Related Establishments / Registrations

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