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

Model Number	CCWET6
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Corneal Edema (1791); Visual Disturbances (2140)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, when the lens was in the eye, noticed that the axis marks on the iol were about 30 degrees counterclockwise from the haptic base.Physician made the assumption that the toric axis marks were correctly placed on the optic and positioned the lens with the iol axis marks at 144 degrees, leaving the haptics at axis 110 degrees.Physician informed patient that this was an unusual situation that not encountered before and physician made the judgement that the axis marks were likely correctly positioned on the iol, but that there was a chance that the axis marks are incorrect in which case patient may need a lens rotation or possibly an iol exchange.There was no patient harm.Patient had mild corneal edema at day one post operative visit with mild hyperopic astigmatism on autorefraction but this was likely to change with resolution of mild corneal edema.Additional information received stating that one-week post operation patient was very happy.Physician dilated left eye and iol axis marks are at 138 degrees (targeted 144 degrees).They will proceed with cataract surgery on right eye next week, also to use a toric iol to correct 3+ d of astigmatism.Post operative corneal edema resolved which was unrelated to iol.
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.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 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: 22015656
• Report Number: 9612169-2025-01052
• Device Sequence Number: 13132449
• Product Code: MJP
• UDI-Device Identifier: 00380652456487
• UDI-Public: (01)00380652456487(17)260106(11)220108(10)25333499
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 01/06/2026
• Device Model Number: CCWET6
• Device Catalogue Number: CCWET6.260
• Device Lot Number: 25333499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 01/08/2022
• 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: ALCON ONLINE TORIC IOL CALCULATOR; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; HEALON OVD; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Age: 61 YR
• Patient Sex: Female