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

Model Number	CCWET3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Corneal Edema (1791); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that the patient underwent lasik but does not know his pre-lasik (laser-assisted in situ keratomileusis) measurements.Based on results physician recommended a company lens and it was implanted.After surgery, 10-0 was put in the main wound as it was leaky.Pow (post operative week) 1 yields crisp vision 20/20 with minimal corneal edema, toric markers aligned, then the 10-0 nylon was removed from main wound at 45 degrees.Pow2 yields crisp 20/20.No clinical corneal edema seen, toric markers aligned.Pow3 patient being seen to assess for stability of mrx (refraction).Additionally patient experienced astigmatic refractive surprise.Surgeon thought that the residual refractive error is from posterior corneal astigmatism for that they don't have the technology to measure.So, the patient was dissatisfied with vision and interested in iol (intraocular lens) exchange, which surgeon inclined to offer within the next few weeks.Additional information has received and it states that there was no impact to the patient and likely planning for iol exchange.Additional information has received and it states that the patient experienced blurry vision.Clinical reason being mentioned as anisometropia and residual refractive error.The iol was explanted and exchanged for an unknown atiol (advanced technology intraocular lens) in the secondary implant procedure.
Additional Manufacturer Narrative
A product was not returned for analysis.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).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 22002947
• Report Number: 1119421-2025-01353
• Device Sequence Number: 20661374
• Product Code: MJP
• UDI-Device Identifier: 00380652455275
• UDI-Public: (01)00380652455275(17)260205(11)220207(10)15346117
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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 Expiration Date: 02/05/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.195
• Device Lot Number: 15346117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/12/2025
• Date Device Manufactured: 02/07/2022
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; ORA SYSTEM WITH VERIFEYE MESSAGING, CART.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; REPLACED WITH UNKNOWN ATIOL LENS.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male