Clareon Vivity Toric Extended Vision Hydrophobic IOL
Received Jul 31, 2026 · Event occurred Jun 15, 2026
Report 9612169-2026-01752 · MDR key 50100869
Device
Generic name
Lens, Intraocular, Toric Optics
Manufacturer
Alcon Laboratories Ireland Ltd.Model number
CNWET2Catalog number
NA
Lot number
26015877
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Blurred Vision
Narrative
Description of Event or Problem
A healthcare professional reported that, after intraocular lens implantation surgery, though the axis was perfectly aligned the patient was not achieving satisfactory visual acuity. The physician has no plausible explanation for this. Hence the lens was explanted and replaced with another noncompany lens in a secondary procedure. Additional information was requested and received stating that postoperatively, the patient experienced poor visual acuity despite only minimal residual refractive error and proper lens alignment, and the physician could not identify a cause for the reduced vision. The patient's vision was considered impaired; however, the outcome was recovered after explanting the lens resulting in improved vision.
Additional Manufacturer Narrative
A product was not returned for analysis. Complaint history and Product History Records were reviewed, and documentation indicated the product met release criteria. Root cause has not been identified.This product is not approved or introduced into commercial distribution in the United States. However, this Medwatch is being filed based on a similar product (CNWET3-T6) (that is sold in the United States under (PMA/510(k) # (P190018).¿ The manufacturer internal reference number is: (b)(4).