inforMED
MalfunctionHQL

Clareon Aspheric Hydrophobic Acrylic IOL

Received Jul 31, 2026 · Event occurred Jul 2, 2026

Report 1119421-2026-01590 · MDR key 50094575

Device

Generic name

Intraocular Lens

Model number

SY60WF

Catalog number

SY60WF.215

Lot number

16117599

Product problems

  • Material Twisted/Bent

Patient

Not reported

  • Insufficient Information

Narrative

Description of Event or Problem

A healthcare professional reported that after an intraocular lens (IOL) implantation procedure, the haptic was not stable.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)