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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, lens was explanted in secondary procedure due to intolerant lens.Additional information was requested.
Additional 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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was returned inside white gauze material that was taped closed and placed into a large biohazard bag.Viscoelastic and fibers from the gauze was observed dried on the lens.The optic was cut into pieces, typical of an insertion and removal.The lens was cleaned with klrp for further evaluation.One optic portion was torn in a semi-circle (still attached) at the edge.Two additional areas of small cracked optic damage were observed near the cut line of damage near the center.Cracks in the shape of an instrument used to grasp the lens were observed on the anterior and directly opposite on the posterior side of the optic.The other optic portion was cracked near the optic center on the anterior surface.Cracks in the shape of an instrument used to grasp the lens were also observed on the anterior optic surface and directly opposite on the posterior side of the optic.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were used with a non-qualified viscoelastic.The root cause cannot be determined for the reported complaint.The explanted lens was returned and evaluated.The lens was cut into pieces, typical of an insertion and removal.Each optic portion had numerous areas of damage.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided that in the surgeon's opinion; the patient was intolerant to the lens.The company 22.5 diopter (1.5 extended depth of focus) lens was removed and replaced with a non-company 22.0 diopter monofocal lens.Due to the exchange of a company diopter lens for a non-company monofocal 22.0 diopter lens, this suggests that a monofocal lens design and one-half diopter less as the replacement lens may have been an improved choice for the patient's vision needs.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• 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: 22096207
• Report Number: 1119421-2025-01521
• Device Sequence Number: 15179928
• Product Code: POE
• UDI-Device Identifier: 00380652405829
• UDI-Public: (01)00380652405829(17)271211(11)231213(10)15768629
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CCWET0
• Device Lot Number: 15768629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: MONARCH CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown