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 Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the patient cant read.The lens was explanted and replaced with another company lens in a secondary procedure.Additional information has been received and stated that there was no patient harm after replacement.
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).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed, and the documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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 on the questionnaire that the non toric company, 24.0 diopter (1.5 extended depth of focus) lens was replaced with a non company, toric (2.25cylinder), 24.0 diopter lens.This information that the company model, non toric lens was exchanged for a toric lens model with 2.25 cylinder power would suggest that patient needed correction for astigmatism.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).

• 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: 19524778
• Report Number: 1119421-2024-01142
• Device Sequence Number: 8251455
• Product Code: POE
• UDI-Device Identifier: 00380652405850
• UDI-Public: (01)00380652405850(17)260425(11)220427(10)15386862(21)15386862009
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 04/25/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.240
• Device Lot Number: 15386862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/27/2024
• Date Device Manufactured: 04/27/2022
• 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 DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; UNSPECIFIED OVD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female