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 Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

The used company cartridge was returned.Inadequate viscoelastic was observed.The cartridge had evidence of placement into a handpiece.No damage was observed.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A qualified handpiece and viscoelastic were indicated.The lens model/diopter was not provided.It is unknown if a qualified lens was used.Product history records were reviewed and the documentation indicated the product met release criteria.No problem was found with the returned used company cartridge.It was reported the "material" could not be removed.The reported foreign material may have been lens damage.It is unknown if the lens used was a qualified model/diopter.The instructions for use (ifu) instructs: use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).The company intraocular lens (iol) delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, it was noted that the cartridge coating was found to adhere to the iol.The physician tried to remove it with irrigation / aspiration (i/a), etc., but could not.The surgery was performed and completed without product replacement.Additional information has been requested.

• 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: 18148546
• MDR Text Key: 328282035
• Report Number: 1119421-2023-01908
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: 15654992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON IOL; MONARCH IV IOL INJECTOR; PROVISC