MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977762

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

A stokist reported that during surgery the cartridge chewed up the lens.Additional information was requested, received and stated there was no patient harm.

Manufacturer Narrative

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 first photo showed the lens carton endcap with the serial number.The lens was in from of the carton, posterior surface up.Viscoelastic and possible blood was observed dried on the lens.The haptics were intact.No torn "chewed" areas were observed.The second photo was the bottom view of a company cartridge.The view was from the loading area to mid-nozzle.The tip was not visible.Unable to observe/determine viscoelastic amount.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• 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 ; 8007579780
• MDR Report Key: 17892593
• MDR Text Key: 325810477
• Report Number: 1119421-2023-01719
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: 00380659777622
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2023

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 Catalogue Number: 8065977762
• Device Lot Number: 15617184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SINGLEPIECE IOL.
• Patient Age: 65 YR
• Patient Sex: Female