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

Model Number	CNW0T4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/28/2025
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 healthcare professional reported that following an intraocular lens (iol) procedure, the lens was rotated in patient after day one of post operation.Additional information has been received that 32 year patient who had high myopia was implanted with the company lens.During day 1 post operation experienced blurry near and distance vision.No corneal edema found.The surgeon explained patient about his eye being abnormally large and told him to come back after 2 weeks for iol rotation.Came back after week and was ok with wearing glasses.Post op 17 days the lens was rotated 54 degrees and after one month 55 degrees.Additional information has been received that in patients opinion lens contributed the event.There are two medical device reports associated with this file.This report is associated with the right eye.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photos were returned.The right eye was operated on in (b)(6) 2025 with a target of -1.50.A pentacam and iol master measured the corneal cylinder to be at an axis between 98 and 105.A company lens +14.0 cyl 2.25 was implanted at axis 98 degrees.One day photo clearly reveals an axis of approximately 45 degrees or rotated 53 degrees from the intended axis.The presentation includes multiple photos confirming the axis of the iol.This was confirmed by itrace.This case demonstrates rotation of a toric iol of approximately 53 degrees nasal from its intended axis.Based on our observation of the attached photos, this case demonstrates rotation of a toric iol of approximately 53 degrees nasal from its intended axis.The root cause for the reported complaint could not be determined based on the returned photos.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 TORIC 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: 21952084
• Report Number: 9612169-2025-00970
• Device Sequence Number: 15587167
• Product Code: MJP
• UDI-Device Identifier: 00380652410045
• UDI-Public: (01)00380652410045(17)280319(11)240321(10)25819819
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/17/2026

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: CNW0T4
• Device Lot Number: 25819819
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 03/21/2024
• 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 DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male