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

Catalog Number 8065977758

Device Problems Defective Device (2588); Device Damaged by Another Device (2915)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for evaluation.Complaint 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).

Event Description

A non-healthcare professional reported that, during the cataract surgery with intraocular lens (iol), when opening the cartridge for company lens in the surgical field, the surgeon observed that cartridge came damaged and missing a tip, identified in the photo.There was no patient harm reported.The surgery was completed with new cartridge.Additional information received and stated that, the issue is a broken haptic post.

Manufacturer Narrative

Based on information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.No further reports required.The manufacturer internal reference number is: (b)(4).

Event Description

Upon further review this complaint was reassessed and confirmed that, this event does not meet criteria for reporting as a reportable malfunction as there was no patient contact with the product and the issue was noted during loading/priming.No further regulatory reports required.

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• 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: 17823216
• MDR Text Key: 324328356
• Report Number: 1119421-2023-01672
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777585
• UDI-Public: 00380659777585
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K001157
• 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,Followup
• Report Date: 11/14/2023

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: 8065977758
• Device Lot Number: 15618329
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female