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	Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non healthcare professional reported that patient experienced fuzzy peripheral vision since having cataract surgery in left eye on (b)(6) 2024.She cannot see at a distance.She measured her vision to be clear at 19-31".She called to ask if this was expected with the lens.Her surgeon said her vision should improve.She had the fellow eye done (b)(6) 2024 and sees great.She wishes the left eye saw as well as the right eye.Her next appointment with her surgeon was (b)(6) 2024.Additional information has been received stating that patient did not understand mini-monovision and target was -0.50 sphere for more near vision with the left eye.She also had mild dysphotopsia.She also had dry eye contributing to her vision complaints.She was doing better after lens placed in right eye with plano target.Prognosis was great.Additional information received from the consumer stating that she was still adapting to the lens.Had cataract surgery with a lens put in my right eye on (b)(6).Can only see well inside with both eyes.The right lens had no clear vision and not enough distance, and as discussed, the left eye only had close vision with no distance.The patient had an appointment on (b)(6) with the surgeon to figure out why my vision was not good.She don't see well outside and especially don't see well driving.Because of this i did not want the lens in my left eye exchanged with the same lens that was put in my right eye.The surgeon gave me a prescription for progressive glasses especially to help me to see distance, and he gave me an non company eye drops prescription for dry eyes.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.The product investigation could not identify a root cause for the reported complaint.Each lens is 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.Information was provided that the company (1.50cyl), 22.5 diopter, (1.5 extended depth of focus) lens was replaced with a company , 21.0 diopter, (1.5 extended depth of focus) lens.The account indicated the product was not available to evaluate.Additional information was provided that the surgeon indicated, "patient did not understand mini-monovision and target was -0.50 sphere for more near vision with the left eye.Patient also has mild dysphotopsia and dry eye contributing to the vision complaints." the exchange for a 1.5 lower diopter difference, change from a toric lens to a non-toric lens model, may suggest that the replacement lens was an improved choice for the patient's vision needs.No further information has been provided at this time.File will be reopened when new information or the product is received.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; 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: 19096500
• Report Number: 1119421-2024-00693
• Device Sequence Number: 7840325
• Product Code: MJP
• UDI-Device Identifier: 00380652455336
• UDI-Public: 00380652455336
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: CCWET3
• Device Catalogue Number: CCWET3.225
• Device Lot Number: 15627475
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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: DUOVISC.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female