MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60WF

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens iol) implant procedure, there was an unidentified plastic like material behind the lens after insertion.Additional information was provided that the surgeon noticed what looked like cortex behind the lens.There were no additional issues.At second day post op, the patient was doing well.There are three medical device reports associated with this facility.This report is associated with 1of 3.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 11574641
• MDR Text Key: 242413723
• Report Number: 1119421-2021-00653
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652332651
• UDI-Public: 00380652332651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.195
• Device Lot Number: 15113428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D