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 Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2024

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 healthcare professional reported with description cartridge split.Additional information has been received that the event occurred while the lens was being advanced into the eye.The surgery was completed with new cartridge and lens.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6.And h.10.The used company cartridge was returned in a small screw top container.A large amount of wet viscoelastic or other liquid was visible in and on the cartridge.There appeared to be mold growth in the liquid.Due to being returned wet, the amount of ophthalmic viscoelastic device (ovd) used cannot be determined.However, information provided stated 1/3 of cartridge filled.This would not be adequate per the instructions for use (ifu).The cartridge had an aneurysm in the top of the nozzle.This split as it entered the thinner tip material.There was also an aneurysm on the right side of the tip.The cartridge had evidence of placement into a handpiece.The used company iii (d) cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was retuned positioned incorrectly in lens case.Viscoelastic was observed on the lens.The optic had scratches from the edge toward the center and scratches across the center of the optic.This damage may indicate a plunger override occurred.Product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation of the monarch cartridge.Qualified associated products were used.The reported cartridge damage was observed.The root cause for the damage appears to be related to a failure to follow the ifu.The account stated the cartridge was filled 1/3 with viscoelastic.The returned lens had damage, which would indicate a plunger override occurred.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 returned company iii (d) cartridge nozzle has an aneurysm that splits as it extends into the thinner tip area.The was an additional aneurysm on the side of the tip.The damage on the top of the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.Damage in the thick cone wall section has been associated with the use of cold viscoelastic.The ifu instructs to use viscoelastic, which has been allowed to come to the operating room temperature.This type of damage may also occur if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge, it can allow the lens fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.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: 18837412
• MDR Text Key: 337189203
• Report Number: 1119421-2024-00417
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 05/02/2024
• 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: ACRYSOF IQ NATURAL SINGLEPIECE IOL.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.