MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET4
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
¿a physician reported that following an intraocular lens (iol) implantation procedure, the patient experienced poor vision.The surgeon noticed that the toric lens was defective, with the toric alignment marks not aligned with the haptic center.Additional information has been received and stated that the symptoms were continued.There was a planned explant and no patient harm.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Photo review: provided photo shows an implanted iol.Toric axis marks on the lens appear to be misaligned.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.6.B., b.5., h.6.And h.11.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the lens was explanted and replaced with unspecified lens in a secondary procedure.Clinical reason for the explant was refractive error miss.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.Provided photo shows an implanted iol.Toric axis marks on the lens appear to be misaligned.The root cause for the reported issue is deemed to be manufacturing related.(root cause most probably relates to human factors where milling machine prompt for realignment was not executed as per procedure).Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implantation procedure, the patient experienced poor vision.The surgeon noticed that the toric lens was defective, with the toric alignment marks not aligned with the haptic center.Additional information has been received and stated that the symptoms were continued.There was a planned explant and no patient harm.Additional information has been received and stated that the lens was explanted and replaced with unspecified lens in a secondary procedure.Clinical reason for the explant was refractive error miss.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22061666
• Report Number: 9612169-2025-01088
• Device Sequence Number: 15406960
• Product Code: MJP
• UDI-Device Identifier: 00380652455718
• UDI-Public: (01)00380652455718(17)260523(11)220525(10)25415889
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2026
• Device Model Number: CCWET4
• Device Lot Number: 25415889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 07/15/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/16/2025; 08/04/2025
• Date Device Manufactured: 05/25/2022
• 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 D; MONARCH III IOL , INJECTOR; UNSPECIFIED VISCOELASTIC
• Patient Age: 73 YR
• Patient Sex: Female