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

Model Number ASKU

Device Problems Crack (1135); Failure to Advance (2524)

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

Event Date 01/25/2023

Event Type  malfunction  

Event Description

A nurse reported that during intraocular lens (iol) implant procedure, the lens could not be advanced, it was pushed out and reloaded in a new cartridge to complete the surgery.After surgery, when inspecting, a crack on cartridge was noticed.There was no patient harm.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.A photo was provided of video monitor.The lower part of a cartridge nozzle and the tip are visible on the screen.The nozzle has a v-shaped crack on the top which splits as it enters the thinner tip.Unable to determined other viscoelastic device (ovd) from the photo.The manufacturer internal reference number is:(b)(4).

• Brand Name: MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• 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: 16370173
• MDR Text Key: 309594825
• Report Number: 1119421-2023-00314
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/14/2023

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 Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE