FDA Adverse Event Malfunction Summary report: N

ACRYSOF IOL

MDR report key: 21573143 · Received March 11, 2025

Report

Report Number: 1119421-2025-00647
Event Type: Malfunction
Date Received: March 11, 2025
Date of Event: February 13, 2025
Report Date: March 11, 2025
Manufacturer: ALCON RESEARCH, LLC - HUNTINGTON
Product Code: HQL
PMA / PMN Number: P930014
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. 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.

Description of Event or Problem · 0

A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS IMPLANTED IN THE EYE IT HAD A HUGE CRACK OR SCRATCH ACROSS THE CENTER. SURGEON DOES NOT KNOW IF THIS WAS AN ISSUE WITH THE TECH WHO LOADED THE LENS OR IT WAS A MANUFACTURER DEFECT. THIS WAS THE THIRD LENS OF THE DAY THAT SHE HAD TROUBLE WITH THOUGH AND GUESSING IT WAS TECH MISHANDLING OF THE LENS. THE LENS WAS INSERTED INTO THE EYE AND HAD TO BE EXTRACTED AND REPLACED IN THE INITIAL PROCEDURE AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1221624	ACRYSOF IOL	INTRAOCULAR LENS	HQL	ALCON RESEARCH, LLC - HUNTINGTON	ASKU	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown