Recall Z-2287-2020 ยท HQL Intraocular Lens
Alcon Research LLC
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.
| Date | Apr 17, 2020 |
| Status | Terminated |
| Reason | Incorrect IOL diopter |
| 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 |
| Quantity | 84 units |
| Distribution | US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.