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 Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A facility representative reported with a description of cartridge split.Additional information has been requested.

Manufacturer Narrative

The samples were returned in a large plastic bag.Two opened company cartridges were returned.One was in an opened company iii (d) cartridge pouch.The second opened cartridge was in a blue self-seal pouch.The opened samples were numbered 1-2 for evaluation purposes.One empty company cartridge pouch was also returned.Thirty-two unopened company cartridges with same lot were returned loose and fourteen unopened company iii (d) cartridges were returned inside the procedure pak cardboard sleeves.(46 unopened samples) five samples were randomly selected from the returned unopened samples.These samples were numbered 1u-5u for evaluation purposes.The company iii (d) cartridge in the opened cartridge pouch was microscopically examined.No damage or abnormalities were observed.The cartridge had no sign of use.The opened company iii (d) cartridge in the self-seal pouch was microscopically examined.Inadequate viscoelastic was observed.The tip had light stress lines.No cracks or split were observed.The end of the tip was bent downward.The cartridge had evidence of placement into a handpiece, but did not appear to have been fully seated.The used company iii (d) cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Five of the returned unopened company iii (d) cartridges were randomly selected.Each cartridge was opened and microscopically examined with no damage observed.All five company iii (d) cartridge were functionally tested per the instructions for use (ifu).No lens or cartridge damage was observed after the lens delivery.The company iii (d) cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.The lens model/diopter and viscoelastic being used were not provided.It is unknown if a qualified combination was used.The reported damage was not observed.The one returned used company iii (d) tip was not cracked or split.The tip had light stress lines.The customer may have been referring to the stress lines.The stress lines observed are an expected occurrence with a lens delivery and do not denote a product deficiency.However, stress lines can be more pronounced if there is an inadequate amount of viscoelastic between the lens and the cartridge lumen or if the lens is not positioned correctly.There appeared to be a lack of viscoelastic in the cartridge.This cartridge also did not appear to have been fully seated into the handpiece.The ifu instruct: slide the cartridge fully forward into the handpiece slot until it is secured firmly into position.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical device (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.Five of the unopened company iii (d) cartridges returned for the reported lot were evaluated.No damage or abnormalities were observed.Functional and dye stain testing was conducted with the unopened samples with acceptable results.No lens or cartridge damage was observed after the functional testing.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: 19077852
• MDR Text Key: 339797735
• Report Number: 1119421-2024-00662
• 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
• Report Date: 04/10/2024

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: 15776518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON IOL.; MONARCH III INJECTOR.