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

Catalog Number 8065977762

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, after implantation of the iol had massive deposits on the upper surface.At first they were practically impossible to remove.Surgeon then turned the cannula and went directly to the lens surface with the suction opening.The deposits could be removed to a large extent.Surgeon is curious how the lens looks next week in mydriasis and whether any residue can be removed with the yag laser.The deposits looked kind of greasy to surgeon.Surgeon added that this would fit because they felt so comfortable on the lens.Surgeon said that where these deposits could have come from is a complete mystery to him - they can't come from the cartridge, since the top is inside the cartridge when it is rolled up.Additional information has been received and stated that continued minor deposits on the iol with increased glare sensitivity.As per the surgeon there was no requirement of medical or surgical intervention.However surgeon also mentioned that possibly later attempt yag polishing.The patient was not hospitalized for the event.

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.A photo was provided.The company cartridge was shown from the bottom view.The cartridge was on top of a the cartridge pouch.The cartridge was determined to be a company cartridge per the wing designation (c).There appeared to be a small amount of ophthalmic viscosurgical device (ovd)/blood at the cartridge tip.No damage could be determined from the photo.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The used company cartridge was evaluated.Viscoelastic was observed in the cartridge.The cartridge nozzle/tip has light stress.No damage was observed.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.No internal damage was observed.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause for the reported foreign material does not appear to be related to the company cartridge.The used company cartridge was returned.No damage or abnormalities were observed.Top coat dye stain testing was conducted with acceptable results.The hcp indicated they did not feel the material was from the cartridge.It cannot be determined if the reported foreign material may have been lens damage as the lens remains implanted.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• 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: 17423096
• MDR Text Key: 320302039
• Report Number: 1119421-2023-01349
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: 00380659777622
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112977
• 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,Followup
• Report Date: 09/25/2023

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: 8065977762
• Device Lot Number: 15365477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF SINGLEPIECE IOL; MONARCH III INJECTOR; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 83 YR
• Patient Sex: Female