MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Viscoelastic was observed on the lens.The lens had been cut from one edge across the center, typical of removal.Part of the optic was pressed between two posts of the lens case, which caused edge damage.The lens was cleaned with klrp (klotho-related protein).The optic had a large scrape mark on the anterior surface, which would indicate a plunger override occurred.The used company cartridge was also returned.Inadequate viscoelastic was observed in the cartridge.The tip had an aneurysm on the bottom and heavy stress.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The returned lens the optic had a large scrape mark on the anterior surface, which would indicate a plunger override occurred.The root cause may be related to a failure to follow the instructions for use (ifu).There did not appear to be adequate viscoelastic in the cartridge.Top coat dye stain testing was conducted with acceptable results.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical 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.Information was provided that the surgeon felt the handpiece plunger may have been bent.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 half turn to engage the threads and then stop.The intra ocular lens (iol) will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that, during intraocular lens implantation surgery, upon insertion surgeon noted that the lens was scratched, but he felt that the inserter arm was bent and had dragged over the top of the lens.Hence the lens was removed and a backup lens was inserted using a new cartridge and loader.There was patient contact.Procedure completed on the same day using another lens.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22069111
• Report Number: 1119421-2025-01455
• Device Sequence Number: 13136928
• Product Code: POE
• UDI-Device Identifier: 00380652405805
• UDI-Public: (01)00380652405805(17)280817(11)240819(10)15898991
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.215
• Device Lot Number: 15898991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON MONARCH IV INJECTOR; CLAREON VIVITY IOL; MONARCH III CARTRIDGE D; PROVISC
• Patient Sex: Unknown