CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL

Report

• Report Number: 1119421-2023-01834
• Event Type: Injury
• Date Received: October 30, 2023
• Report Date: October 30, 2023
• Manufacturer: ALCON RESEARCH, LLC - HUNTINGTON
• Product Code: MJP
• UDI-DI: 00380652455244
• PMA / PMN Number: P190018
• Removal / Correction Number: NA
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: NJ, US
• Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

A SAMPLE DEVICE 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 HAD HALO. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS IOL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
131436	CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL	LENS, INTRAOCULAR, TORIC OPTICS	MJP	ALCON RESEARCH, LLC - HUNTINGTON	CCWET3	15354717	00380652455244

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention

Terms

Patient problem · 1

• Halo

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission