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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
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 non health care professional reported that after surgery reported that the lens was explanted due to the reason of missed target.Additional information has been receive it states that there is no impact to the patient.
Additional Manufacturer Narrative
Correction information was provided in d.4.Product udi has been updated.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.Additional information has been provided in a2., a3.A.,b2.,b5.,d4.,e1.,h.3., h.6., and h.11.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.Information was provided that the cause of the event was related to a residual refractive error and a missed target.Based on the information provided, the event is most likely related to a calculation error.The product has not been received to evaluate.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Additional information was provided that the company (1.50cyl), 19.0 diopter, (1.5 extended depth of focus) lens was replaced with a company (1.50cyl), 20.0 diopter, (1.5 extended depth of focus) lens.No further information has been provided at this time.File will be reopened when new information 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: 20464243
• Report Number: 1119421-2024-02022
• Device Sequence Number: 20774664
• Product Code: MJP
• UDI-Device Identifier: 00380652455268
• UDI-Public: (01)00380652455268(17)260501(11)220503(10)15401499
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 05/01/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.190
• Device Lot Number: 15401499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/04/2024
• Date Device Manufactured: 05/03/2022
• 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: DUOVISC VISCOELASTIC SYSTEM.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; UNSPECIFIED FOLDING FORCEPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male