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 Defective Component (2292); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2023

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 cartridge was chipped, which caused the lens to segment.The doctor replaced it with another lens and the surgery was completed.Additional information was requested, but no further information is available.

Manufacturer Narrative

A used company cartridge was returned with a lens case inside the lens carton.Viscoelastic was observed in the cartridge.A portion of broken optic was observed in the cartridge nozzle near the fill line.The posterior of the nozzle was stressed and had a large crack.The crack enlarged to become split damage as it intended into the thinner tip area.The cartridge displayed evidence of being placed into a handpiece.The remainder of the lens was returned positioned incorrectly in a lens case.Solution was dried on the lens.A section of the optic was broken off and returned inside the cartridge.The optic edge was chipped.Both haptics were bent in the gusset areas.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.A qualified cartridge and handpiece were used.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause for the reported complaint could not be determined.The returned company cartridge nozzle has a heavy stress and a large crack that split as it extended into the thinner tip area.The damage on the posterior 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 instruction for use (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 to fold around the plunger tip making it too large to correctly advance.It is unknown if a qualified viscoelastic was used.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 viscosurgicaldevice (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Top coat dye stain testing was conducted with acceptable results.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: 17931695
• MDR Text Key: 325623468
• Report Number: 1119421-2023-01749
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: K063155
• 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: 11/24/2023

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: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ TORIC SINGLEPIECE IOL; MONARCH III INJECTOR
• Patient Sex: Female