CLAREON PANOPTIX PRO Trifocal TORIC IOL w/AutonoME Delivery System
Received Jul 31, 2026
Report 9612169-2026-01751 · MDR key 50099458
Device
Generic name
Lens, Intraocular, Toric Optics
Manufacturer
Alcon Laboratories Ireland Ltd.Model number
PXYAT3Catalog number
PXYAT3.115
Lot number
26141845
Product problems
- Device Difficult to Setup or Prepare
- Device Dislodged or Dislocated
Patient
Not reported
- Visual Impairment
Narrative
Description of Event or Problem
A non health care professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced vision blurry. Clinical reason being IOL was rotated off toric axis and found to have defective haptic that did not fully expand. The IOL was explanted and exchanged for an same company model lens and diopter 7 days following the initial implant procedure.Additional information has been requested but is not available at the time of this report.
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. The manufacturer internal reference number is: (b)(4).