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 Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

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

Event Date 10/29/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A non healthcare professional reported that during the intraocular lens (iol) implant procedure, the cartridge was split as lens was going into eye and scratched the lens.The iol was removed from eye.The surgery was completed with a back up lens during the initial procedure with no patient harm.

Manufacturer Narrative

A company cartridge and the associated lens were returned inside the lens carton.Viscoelastic was dried in the cartridge.The tip had heavy stress lines that enlarged to an aneurysm that has torn along the posterior throughout the tip exit.The torn cartridge material at the exit was stretched and twisted.The cartridge has evidence of handpiece use.The associated qualified lens was returned positioned correctly in the lens case.Viscoelastic was dried on the lens.The lens was cleaned with klrp to further evaluate.The posterior optic was scratched and cracked near the optic center.Product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Information was provided that indicated the use of a qualified¿lens, handpiece and viscoelastic.The reported tip damage and lens damage were observed.The root cause cannot be determined for the reported complaint.The damage observed to the tip of the used cartridge typically occurs if the lens is not positioned correctly/folded correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; and/or if the handpiece plunger is not positioned correctly at the trailing optic edge.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge causing damage.The associated lens instructions for use (ifu) instructs: follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens (iol) to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.Information was provided that a facility representative called to report company cartridge split as lens was going into eye, scratched the lens.The lens was not all the way in and was safely removed from eye, the case was completed with a backup lens.The back up lens information was not provided.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: 18199220
• MDR Text Key: 328923874
• Report Number: 1119421-2023-01978
• 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
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/23/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV INJECTOR; CLAREON TORIC UV ABSORBING IOL; DUOVISC
• Patient Age: 75 YR
• Patient Sex: Male