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

Model Number	CNWET3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure, on the first day following surgery, the patient demonstrated visual acuity was good.On the fourth day, there was a deterioration in vision.Implant axis check showed that the intraocular lens (iol) had rotated from its original implant axis.Repositioning of the iol was planned.Additional information has been received stating after three weeks of post-surgery patient was satisfied, but has difficulty seeing at a distance.Repositioning of the iol has been performed recently.
Additional Manufacturer Narrative
The product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in h.3., h.6.And h.11.The product was not returned for analysis.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.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 ; 8007579780
• MDR Report Key: 23484598
• Report Number: 9612169-2025-02217
• Device Sequence Number: 10237786
• Product Code: MJP
• UDI-Device Identifier: 00380652485548
• UDI-Public: (01)00380652485548(17)290121(11)250123(10)25981767
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET3
• Device Lot Number: 25981767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 01/23/2025
• 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: OCUCOAT 2%.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male