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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

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).

Event Description

A non healthcare professional reported that, during intraocular lens implantation surgery, the lens was placed into the inserter and when the surgeon was advancing the lens halfway, the surgeon noticed scratch on the lens.However, the surgeon still continued to advance the lens stating that due to patient's eye medical history, removing the lens would cause more harm to the patient.Hence the lens was left implanted inside the patient's eye.The scrub technician believed that, the top portion of the notch that pushes the lens in the inserter was the one that caused the scratch.There was no patient harm as the scratch was not in the visual axis.The lens is still implanted in the patient's eye and as per the surgeon's opinion, the prognosis of the patient was good.

Manufacturer Narrative

The product was not returned.A photo was provided of an implanted single-piece lens.A black arrow denoted the area of interest.There appeared to be a chip/gouge a the optic edge.This damage may have been caused by a plunger override.No other determination can be made from the photo.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported lens damage.The company cartridge was not returned.Not enough information was provided for further investigation.Based on review of the provided photo, the lens was chipped or gouged on the anterior edge.This may have been interpreted as the reported "scratch".This damage was similar in appearance to damage caused by a plunger override.The instructions for use (ifu) instructs to completely fill the cartridge with ophthalmic viscoelastic device (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.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.The handpiece ifu instructs: 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 intraocular lens (iol) will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the 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.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: 18675167
• MDR Text Key: 335100709
• Report Number: 1119421-2024-00227
• 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: 04/26/2024

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?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/31/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON IOL.; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 43 YR
• Patient Sex: Female