Clareon PanOptix Trifocal UV Absorbing Intraocular Lens

Description of Event or Problem

A non healthcare professional reported that, after intraocular lens implantation surgery, the patient had experienced mispositioning of the IOL (Intraocular lens) in the left eye. Hence the lens was explanted and replaced with another lens in a secondary procedure. The clinical reason for explant was dislocated Intraocular lens.Additional information was requested and received stating that they chose a multi focal lens. It eventually dislocated and a new one had to be placed. there was no patient harm. The patient issue resolved and the surgeon's prognosis was good. The replaced lens were non-company ones.

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).