MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon Vivity Toric Extended Vision Hydrophobic IOL; Lens, Intraocular, Toric Optics

Model Number	CNWET4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following an intraocular lens (iol) implantation procedure, the patient ended up with a massive refractive error (-7.50 diopter), despite the iol powers being very close on both sides and the biometry being comparable.Additionally, his pre-op refraction was also equal on both sides.The surgeon was doubtful and concerned whether the correct iol was in the box as the surgeon had never encountered such a big anisometropia in a patient with comparable biometrics on both sides and similar refractive error on both sides pre-op.The surgeon referred the patient to a refractive surgeon.Additional information has been received and stated the iol was not explanted and a refractive surgery (without charge) on the patient was performed and achieved good results.The patient was satisfied with the results.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined.The manufacturing batch records confirm that the product met release criteria.Investigation has been completed based on current information.No further action is warranted at this time.Based on our trend analysis, there are no adverse trends identified for this complaint and based on these findings the residual risk remains at an acceptable level.The manufacturer internal reference number is: (b)(4).

• Brand Name: Clareon Vivity Toric Extended Vision Hydrophobic 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 ; +1(800)757-9780
• MDR Report Key: 50773461
• Report Number: 9612169-2026-02068
• Device Sequence Number: 9717632
• Product Code: MJP
• UDI-Device Identifier: 00380652466691
• UDI-Public: (01)00380652466691(17)270211(11)230213(10)25595243
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Model Number: CNWET4
• Device Lot Number: 25595243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 02/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown