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 Date 01/05/2024

Event Type  malfunction  

Event Description

A non-healthcare professional reported that during insertion of the intraocular lens (iol), during an implant procedure, a scratch /scuff was noticed on the posterior side of the lens and there was acrylic material hanging from the optic.The loose material was removed with the irrigation and the aspiration.The lens was left inside the eye as the scratch was peripheral to the visual axis.Additional information has been requested; however, further information has not been received.

Manufacturer Narrative

The used company cartridge was returned for evaluation.Inadequate viscoelastic was observed in the cartridge.The cartridge tip had heavy stress and an internal scrape on the right side.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted.The cartridge met specification for the presence of top coat.An internal disruption was observed on left side of tip at the damaged area.A photo was provided of a clear, single-piece lens in the eye.A linear mark was observed.The mark was at an angle to the fold/travel path and may have been a crack.There also appeared to be three small marks near this area.The observed marks may have been caused by an instrument used to grasp the lens or by the plunger during advancement.Product history records were reviewed and documentation indicated the product met release criteria.A qualified handpiece and viscoelastic were indicated.The associated company lens model is only qualified for use with the company cartridge.The root cause for the reported lens damage may be related to a failure to follow the ifu.Based on the provided photo, a linear mark was observed.The mark was at an angle to the fold/travel path and may have been a crack.There also appeared to be three small marks near this area.The observed marks may have been caused by an instrument used to grasp the lens or by the handpiece plunger.The observed material may have been from the damage cartridge tip.The associated company lens model is only qualified for use with the company cartridge.Inadequate viscoelastic was also observed in the cartridge.Per the ifu: 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 ifu also 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 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: 18629103
• MDR Text Key: 334407725
• Report Number: 1119421-2024-00185
• 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: 02/02/2024

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: 15734692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR