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 Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A non-healthcare professional reported with a description of during intraocular lens (iol) implant procedure, the haptics was severed off when implanting in eye as well as 2 large scratches on the iol.They were not sure if it the injector, the cartridge or lens failure.The lens was explanted and replaced with another lens during initial procedure.The procedure was completed.Additional information has been requested.

Manufacturer Narrative

The company cartridge was returned with the damaged lens on a medical sponge in a specimen jar.Inadequate viscoelastic was observed in the cartridge.The cartridge nozzle has stress that has enlarged into an aneurysm along the anterior.The nozzle damage began in the thick nozzle cone wall.The aneurysm extended into the thinner tip area along the anterior.The tip has multiple stress lines.The cartridge wings displayed evidence of being placed into a handpiece.Photos were provided that displayed the back of the cartridge pouch with product information.The other two photos displayed the lens inside the eye with broken haptic damage and what appeared to be torn and split damage.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens and handpiece were used.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.Based on the evaluation of the returned cartridge, the photos provided in the file of the extremely damaged lens in the eye, and the evaluation of the returned lens showing the reported damage, the root cause of the reported damage was most likely related to a failure to follow the instruction for use (ifu).An inadequate amount of viscoelastic¿was observed in the cartridge.The ifu instructs to completely fill the cartridge with 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.The returned company cartridge nozzle has an aneurysm¿that extended 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 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.It is unknown if a qualified viscoelastic was used.The 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 a 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: 19173978
• MDR Text Key: 340951238
• Report Number: 1119421-2024-00791
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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: 15776512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Date Manufacturer Received: 03/27/2024
• 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 ASPHERIC UV ABSORBING IOL.; GRIESHABER 560.01.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; UNSPECIFIED REPLACEMENT LENS.