Recall Z-2287-2020
Alcon Research LLC · initiated April 17, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1
Reason for recall
Incorrect IOL diopter
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2287-2020
- Initiated
- April 17, 2020
- Terminated
- February 5, 2021
- Product code
- HQL – Intraocular Lens
- Quantity
- 84 units
- Distribution
- US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
- Recalling firm
- Alcon Research LLC, Fort Worth, TX