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

Catalog Number 8065977763

Device Problems Appropriate Term/Code Not Available (3191); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

A non healthcare professional reported that during an intraocular lens (iol) implant procedure, the cartridge split.The lens was not loaded properly originally so they pushed the lens out through the cartridge and reloaded the lens again in the same cartridge.Additional information was requested.

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.  there have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A qualified lens model/diopter was indicated.The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.The root cause may be related to a failure to follow the instruction for use (ifu).Cartridges are single-use devices.Information was provided that the lens was not loaded properly originally so they pushed the lens out through the cartridge and reloaded the lens again in the same cartridge.This is a re-use of the device.The ifu states: do not reuse the cartridge.The cartridge is for single use only.Reuse of this single-use device may result in serious injury.Potential risks from reuse or reprocessing include: a damaged cartridge, a damaged lens, an unexpected delivery outcome, and contamination of the cartridge.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• 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: 12989241
• MDR Text Key: 282204831
• Report Number: 1119421-2021-02369
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 15234260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SP IOL