FDA
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.
Incorrect IOL diopter
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.