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 Problems Defective Component (2292); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

The sample product was not returned.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Cartridge manufacturing is a validated operation, with specifications that are maintained and documented.No changes have been made for the manufacturing of cartridges.Supplier manufacturing records as well as their certificate of compliance verify the dimensional measurements are within specifications.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that, during intraocular lens implantation surgery, when the physician tried to insert the lens into the cartridge, it did not go in smoothly.The aperture of the cartridge felt wider than usual, which caused loosening and did not allow for proper tacking of the trailing haptic.The lens was then removed from the patient's eye and the same lens was used with a new cartridge and the surgery was completed successfully.The surgeon also mentioned that the cartridge was different than usual, but he managed to insert it with that cartridge.There was no patient harm.Additional information has been requested.

Manufacturer Narrative

The lens diopter was not provided.It cannot be determined if the lens was qualified.A non-qualified handpiece and viscoelastic were indicated.The root cause for the reported "aperture was different" could not be determined.The company cartridge was not returned for evaluation.A determination cannot be made without physical examination of the product.Cartridge manufacturing is a validated operation, with specifications that are maintained and documented.No changes have been made for the manufacturing of cartridges.Supplier manufacturing records as well as their certificate of compliance verify the dimensional measurements are within specifications.The reported issue may be related to the use of a non-qualified cartridge and viscoelastic.It cannot be determined if the lens was a qualified diopter.The instruction for use (ifu) instructs: the company iol delivery system is for implantation of qualified company foldable iols.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols 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).

• 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: 17824830
• MDR Text Key: 324355220
• Report Number: 1119421-2023-01694
• 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,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• 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: 15654985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ASICO PUSH TYPE INJECTOR; CENTURION VISION SYSTEM; CLAREON TORIC IOL; OVD: HEALON; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE