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 Crack (1135); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Two photos were provided that show the company cartridge inserted into a company handpiece.The plunger is at mid-nozzle.There does not appear to be viscoelastic in front of the plunger.The tip of the cartridge is split on the bottom.There appears to be a piece broken from the tip.There also appears to heavy stress, possibly an aneurysm on the side of the tip.This excessive damage would indicate the lens/plunger were not is correct positions for advancement.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during the intraocular lens implantation there was no issue with the lens loading process, but in the process of pushing the plunger, the blockage occurred inside of the cartridge during the lens implantation process and the surgeon felt that something was stuck at the end of the cartridge.After the lens was implanted into the patient, a crack was observed on the lens.After the surgery, the injector and cartridge used in the surgery were checked, and the broken part was found in the cartridge.Although the patient did not complaint of discomfort, there is a possibility of future iol exchange due to crack.No further information is available.

Manufacturer Narrative

Information was provided that indicated the use of a handpiece qualified for use with the company cartridge when used with a qualified lens.The lens model and diopter information were not provided.It cannot be confirmed that a qualified lens was used.A non-qualified viscoelastic was indicated.Based on the information in the file and evaluation of the provided photos, the root cause may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Heavy damage was observed to the tip of the cartridge and a broken portion of the lens was observed inside the cartridge in the plunger groove in the provided photos.This excessive damage also would indicate the lens/plunger were not in correct positions for advancement.If additional information becomes available regarding this file, the file will be reopened and updated.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: 15995669
• MDR Text Key: 308082692
• Report Number: 1119421-2022-02690
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 10380659777636
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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: 8065977763
• Device Lot Number: 15343476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV INJECTOR; HYALU INJ. 1%