CLAREON ASPHERIC UV ABSORBING IOL

Report

• Report Number: 1119421-2025-02736
• Event Type: Injury
• Date Received: October 22, 2025
• Report Date: October 22, 2025
• Manufacturer: ALCON RESEARCH, LLC - HUNTINGTON
• Product Code: HQL
• UDI-DI: 00380652396875
• PMA / PMN Number: P190018
• Removal / Correction Number: NA
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: NY, US
• Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

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).

Description of Event or Problem · 0

A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON AS IOL CAME TOO STRONG AND CLINICAL REASON FOR EXPLANT BEING BLURRY VISION IOL CAME TOO STRONG. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
242890	CLAREON ASPHERIC UV ABSORBING IOL	INTRAOCULAR LENS	HQL	ALCON RESEARCH, LLC - HUNTINGTON	CC60WF	15987370	00380652396875

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention

Terms

Patient problem · 1

• Blurred Vision

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission