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	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient vision was not well i.E, not able to see tv or street signs.Clinical reason being mentioned as lens implant is not at the intended target.The iol was explanted and exchanged for an unknown atiol lens following the secondary implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in a.2.,a3.A.,b.3., b6.,b.5., d.10., e.4.,h.3., h.6., and h.11.The product has not been received to evaluate.Each lens is subjected to a 100 percentage 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, 16.5 diopter, lens was replaced with an company, 15.0 diopter lens.The exchange for the same model with a 1.5 changed in diopter, would indicate the 15.0 diopter better met the patient's visual needs.Additional information was provided that the clinical reason for the exchange was that the original implant was not the intended target, which may indicate a calculation issue.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information states that after 29 day post-operation patient struggles to see tv and distance is very blurry.Patient had lens exchange with another lens.Patient had a 2 diopter myopic shift in the left eye after cataract surgery with a company lens despite choosing the correct iol power on the a scan targeting good distance vision.There was no impact to the patient.

• 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; 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: 20535785
• Report Number: 1119421-2024-02098
• Device Sequence Number: 12843375
• Product Code: POE
• UDI-Device Identifier: 00380652405706
• UDI-Public: (01)00380652405706(17)260910(11)220912(10)15431601
• 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
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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 Expiration Date: 09/10/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.165
• Device Lot Number: 15431601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/05/2024
• Date Device Manufactured: 09/12/2022
• 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: CLAREON MONARCH IV IOL, INJECTOR; CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; MONARCH II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female