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 Codes	Corneal Edema (1791); Posterior Capsule Opacification (4807)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.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 nurse reported that, after intraocular lens implantation surgery, the patient experienced mild diffuse flap edema and grade 2 posterior capsule opacification (pco) with striae through visual axis.Hence yttrium aluminum garnet (yag) was performed to treat pco.In the surgeon's opinion, the possible cartridge material or the lens would have caused the event.There was no patient harm.In the surgeon's opinion, the prognosis of the patient was good.
Additional Manufacturer Narrative
Additional information was provided in h.11.The product was not returned.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Qualified associated products were indicated.The root cause for the reported events could not be determined.The lens remains implanted.Regarding the findings of posterior capsule opacification (pco), anterior capsule opacification (aco), phimosis, and intra ocular lens (iol) rotation off-axis with company lenses, the company director of global technical customer affairs consulted with the surgeon and provided information related to the reported events.Because these findings are related to clinical outcomes, review of complaints for the reported event types is the primary investigation focus to assess for potential concerns related to anterior/posterior capsule opacification, phimosis, and lens rotation.Information was also provided that because clinical outcomes are complex with numerous potentially associated clinical and surgical factors, additional information could be discussed with the account representative, including options such as a peer-to-peer communication service called expert opinion md, that alcon offers at no charge.Reports of these event types have remained low and stable, with intermittent reporting as expected, based on the potential multifactorial etiology.An additional global review was conducted to look at the reported incidence for each of the above outcomes over the past 3 years.All global complaints are evaluated monthly for adverse trending, and no adverse trends were identified for these events.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.

• 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: 22174413
• Report Number: 1119421-2025-01627
• Device Sequence Number: 7829047
• Product Code: POE
• UDI-Device Identifier: 00380652405843
• UDI-Public: (01)00380652405843(17)271008(11)231010(10)15727280
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 15727280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/11/2025
• Date Device Manufactured: 10/10/2023
• 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: CLAREON MONARCH IV INJECTOR; DUOVISC VISCOELASTIC SYSTEM; MONARCH II LOADING FORCEPS; MONARCH III CARTRIDGE D
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female