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

Model Number	CCA0T3
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.The returned photo shows an implanted intraocular lens (iol).The toric axis marks are misaligned.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
An ophthalmologist reported that during intraocular lens (iol) implantation, it was noted that the lens dots were not aligned precisely to the haptics.The lens was aligned according to the dots to correct astigmatism.It was not explanted; it remains in patient's eye.There was no patient injury.The surgeon plans to follow up with the patient to evaluate the postoperative outcome.Based on new information received, the patient¿s postoperative refraction is +0.50 / -0.50, and the patient is doing well.
Additional Manufacturer Narrative
Additional information provided in sections h.3., h.6., and h.11.The product was not returned for analysis, only photo was returned.The reported complaint was observed on the returned photo.The root cause for the reported complaint is deemed to be manufacturing related.The product did not meet specifications.The toric axis marks are misaligned; they do not meet the location specifications as per approved manufacturing procedures.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC ASPHERIC UV ABSORBING 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: 23988181
• Report Number: 9612169-2026-00042
• Device Sequence Number: 17300759
• Product Code: MJP
• UDI-Device Identifier: 00380652440356
• UDI-Public: (01)00380652440356(17)280626(11)240628(10)25875723
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCA0T3
• Device Lot Number: 25875723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 06/28/2024
• 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
• Patient Sex: Unknown