FDA Adverse Event Injury Summary report: N

ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL

MDR report key: 16521574 · Received March 10, 2023

Report

Report Number: 1119421-2023-00432
Event Type: Injury
Date Received: March 10, 2023
Date of Event: September 23, 2022
Report Date: March 10, 2023
Manufacturer: ALCON RESEARCH, LLC - HUNTINGTON
Product Code: MFK
UDI-DI: 00380652429726
PMA / PMN Number: P040020
Removal / Correction Number: NA
Report Source: Manufacturer report
Reporter Location: UT, 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem · 0

A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION (IOL) IT WAS NOTICED THAT THE 80% OF THE HAPTIC WAS BISECTED. THE PATIENT HAD EXPERIENCED GLARE AND HALOS. HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE OPTIC WAS 80-90% BISECTED (CLEAN) AT THE OPTIC/HAPTIC JUNCTION. THE PATIENT SYMPTOMS HAVE RESOLVED AND THE PROGNOSIS WAS EXCELLENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1308316	ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL	LENS, MULTIFOCAL	MFK	ALCON RESEARCH, LLC - HUNTINGTON	TFAT00	15338325	00380652429726

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR	Male	Required Intervention	MCPHEARSONS FORCEPS\| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D\| MONARCH III IOL DELIVERY SYSTEM, INJECTOR\| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE