MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNA0T3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure, 7 days post-operation the surgeon noticed that the lens was rotated 60 degrees.The surgeon repositioned the lens in the operation theatre 36 days after the initial implant procedure.Additional information was requested and received.The surgeon checked the lens after re-rotation and noticed that it had once again rotated (85 degrees instead of 110).The surgeon suspected there was an odd haptic.He planned to review the patient in 3 months and possibly perform a top-up laser.Surgeon did not want to go into the eye again.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.Photo provided shows an image of the iol alignment.Reported complaint cannot be determined from the picture provided.The reported complaint cannot be confirmed from the provided photo.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM
• 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: 23092882
• Report Number: 9612169-2025-01861
• Device Sequence Number: 15868782
• Product Code: MJP
• UDI-Device Identifier: 00380652398817
• UDI-Public: (01)00380652398817(17)270801(11)230803(10)25692514
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: CNA0T3
• Device Lot Number: 25692514
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 08/03/2023
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female