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 Break (1069)

Patient Problem Eye Injury (1845)

Event Date 07/22/2023

Event Type  Injury  

Event Description

A healthcare professional reported that during an intraocular lens (iol) implant procedure, the cartridges ruptured during iol implantation.The iol implantation was completed with forceps by enlarging the incision.The product had contact with the patient, but there was no harm to the patient.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A non-company lens was indicated.The handpiece and viscoelastic used were not provide.It is unknown if qualified products were used.The product was not returned.Based on the provided information the root cause is most likely related to a failure to follow the instruction for use (ifu).A non-company lens was indicated.It is unknown if a qualified handpiece and viscoelastic were used.The instruction for use (ifu) instructs: the company iol delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.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 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: 17622065
• MDR Text Key: 321918383
• Report Number: 1119421-2023-01510
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: 00380659777622
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977762
• Device Lot Number: 15585641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IOL LW625A; MCPHERSON FORCEPS
• Patient Outcome(s): Other
• Patient Sex: Female