inforMED
InjuryMFK

CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS

Received Jul 10, 2026

Report 1119421-2026-01451 · MDR key 25780951

Device

Generic name

Lens, Multifocal Intraocular

Model number

CCWTT0

Catalog number

CCWTT0.215

Lot number

15744701

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • 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 DECREASED IN NEAR VISION AND COLORS APPEARED PALE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 8 MONTHS, 16 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.