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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

A non-health care professional reported with the description of split cartridge and there was patient contact.Additional information was received and there was no patient harm.

Manufacturer Narrative

Two used qualified company cartridges were returned.Viscoelastic was observed in the cartridges.Both cartridges show evidence they were placed into a handpiece.Both of the returned company cartridge nozzles have heavy stress and a large crack that extends into the thinner tip area.The damage on the top of the nozzle started in the thick wall cone area.Complaint and product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of a qualified lens and handpiece.The associated viscoelastic was not provided.It is unknown if a qualified product was used.The root cause for the reported complaint could not be determined.Both of the returned company cartridge nozzles have heavy stress and a large crack extends into the thinner tip area.The damage on the top of the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.Damage in the thick cone wall section has been associated with the use of cold viscoelastic.The instruction for use (ifu) instructs to use viscoelastic, which has been allowed to come to the operating room temperature.This type of damage may also occur if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge, it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.Follow-up attempts were conducted.Not enough information was provided to determine if a qualified viscoelastic was used.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.Company foldable intra ocular lens (iol) 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 lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information was provided in h.3.,h.6 and h.11.The file indicated the use of a viscoelastic that is non-qualified for the lens/company combination.The root cause for the reported complaint appears to be related to a failure to follow the instructions for use (ifu).The file indicated the use of a viscoelastic that is non-qualified for the lens/company combination.The ifu also instructs that company foldable intra ocular lens (iol) 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.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19162558
• MDR Text Key: 340803270
• Report Number: 1119421-2024-00775
• 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: 04/23/2024

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: 15766044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; CLAREONVIVITYTORIC EXTENDED VISION UVABSORBING IOL.; SMOOTH CURVED FIEV FORECEPS.; STABLE VISC.
• Patient Age: 72 YR
• Patient Sex: Male