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 facility representative reported with a description of damaged lens.The lens had small detects on the edge and left implanted.Additional information was requested.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The used company cartridge was returned.The cartridge was microscopically examined.There appeared to be inadequate viscoelastic in the cartridge.The tip had heavy stress and a large aneurysm on the left side.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The cartridge returned for this file matched the second cartridge in photo #1 and matched photo #2.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens model/diopter, handpiece and viscoelastic were indicated.The root cause of the reported lens edge damage could not be determined.Based on the provided photo the damage was a chip, not a scratch.The returned used company cartridge was damaged.The tip had heavy stress and a large aneurysm on the left side.Top coat dye stain testing was conducted with acceptable results.The damage observed to the tip of the used cartridge (large aneurysm and heavy stress) typically occurs if the lens is not positioned/folded correctly for advancement 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 without causing damage.The placement of the lens damage and the cartridge tip damage would support the plunger was not in a proper position for delivery, information was provided that adequate ovd was used in the cartridge and the lens was delivered within 2 minutes of loading.Residual ovd observed may indicate the cartridge was not filled as indicated.The handpiece ifu instructs: important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.Verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The company cartridge 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.Use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).Results of the product evaluation were provided to the training group and global quality customer affairs.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: 18391709
• MDR Text Key: 331292127
• Report Number: 1119421-2023-02208
• Device Sequence Number: 1
• Product Code: MSS
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

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: 15732834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL.; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Patient Age: 81 YR
• Patient Sex: Female