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

Model Number	CNW0T6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2025
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 physician reported that following intraocular lens implant procedure, lens was explanted due to lens subluxation.The lens was exchanged with an unknown monofocal intraocular lens after the initial implant procedure.
Event or Problem Description
Additional information received stating that in the surgeon¿s opinion product did not contribute to the event.Capsular compromise caused the event.The patient's issues resolved.
Additional Manufacturer Narrative
Additional information was provided in a1, a2, a3.A, b3, b5, b6, b7 and e4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Additional information: the surgeon determined that the subluxation of the lens was due to capsular compromise and not caused or contributed to by the product.The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as surgeon determined that the subluxation of the lens was due to capsular compromise and not caused or contributed to by the product.Based on this information, the product did not cause/contribute to the event.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: 22175865
• Report Number: 9612169-2025-01209
• Device Sequence Number: 18100087
• Product Code: MJP
• UDI-Device Identifier: 00380652402415
• UDI-Public: (01)00380652402415(17)270717(11)230719(10)25686524
• 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
• 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): 09/05/2025

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: CNW0T6
• Device Lot Number: 25686524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 08/15/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/04/2025; 09/05/2025
• Date Device Manufactured: 07/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF MULTIPIECE IOL; REPLACEMENT LENS: UNSPECIFIED MONOFOCAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female