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

Model Number	CCWET5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Retinal Detachment (2047); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	09/04/2024
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 facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced saturation/sharp vision and lens has been explanted 8 months following the initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that patient experienced suboptimal vision and vision was out of focus at all distance.In surgeon opinion decreased acuity and astigmatic position correction caused or contributed the event.The patient had retinal detachment following surgery and vitrectomy.She also had yag (neodymium-doped yttrium aluminium garnet) laser before explant.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in h.3.Corrected information provided in h.6.Correction: on initial mdr the patient code of e083901 was an error.It should have been e081903 on the original mdr.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: 20805039
• Report Number: 1119421-2024-02325
• Device Sequence Number: 21289729
• Product Code: MJP
• UDI-Device Identifier: 00380652456098
• UDI-Public: (01)00380652456098(17)260425(11)220427(10)15401492
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 02/17/2025

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: 04/25/2026
• Device Model Number: CCWET5
• Device Catalogue Number: CCWET5.245
• Device Lot Number: 15401492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 01/22/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 12/31/2024; 02/18/2025
• 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: MONARCH III IOL CARTRIDGE C; MONARCH III IOL INJECTOR; PROVISC OVD; TORIC LENS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female