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 Problems Crack (1135); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A facility representative reported with a description of defect in some company cartridges.It was identified that there was a crack at the tip of some cartridges and some cartridges damaged intraocular lenses (iols) during implantation.Additional information has been requested.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.3., and h.6., and h.10.A photo was provided.The view was from the side.The focus was blurry.Glare on the nozzle did not allow for visibility of damage.The tip appeared split on the side.A video was also provided.The video showed the same view as the photo.The cartridge was rotated several times.The view was blurry.There appeared to be a crack in the nozzle starting just before the parting line and traveling into the tip where it looked like a split occurred.Unable to determine "ophthalmic viscoelastic device (ovd) amount due to the quality of the photo/video.The cartridge had evidence of placement into a handpiece.Associated product information was not provided.It is unknown if qualified associated products were used.Based on review of the provided photo and video the tip appeared damaged.The company cartridges were not returned for evaluation.No determination can be made without physical examination of the product.It is unknown if qualified associated products 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 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 file will be reopened if the product or new information is received.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: 17736988
• MDR Text Key: 323283930
• Report Number: 1119421-2023-01600
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2023

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: 8065977762
• Device Lot Number: 15585640
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/23/2023
• 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