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	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that the leading haptic was exposed and out of the nozzle tip before insertion.The issue occurred during intraocular lens (iol) implantation procedure.There was patient contact.According to the new information received, the issue occurred intraoperatively during the implantation attempt.The surgery was completed on the same day.The surgeon was uncertain about the cause of the issue, suggesting it could be due to a device defect or a product-related factor.There was no harm to the patient, and the surgeon reported a good prognosis.
Additional Manufacturer Narrative
Additional information provided in sections d.9., h.3., h.6., and h.11.The product was returned for evaluation, and the reported complaint could not be observed.The device was received in a blister tray inside the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been fully advanced outside the nozzle.No damage observed.The lens was returned outside of the device.Solution is dried on the intraocular lens (iol).One haptic is adhered to the optic surface with solution.No damage observed.Based on the information received, the investigation could not determine the root cause for the reported complaint.The presentation of straight leading haptics is addressed in the product instructions for use (ifu), where it is provided that delivery may proceed with caution and should be managed based on the outlined instructions.While straight leading haptics may occasionally occur, close adherence to the ifu provides the best opportunity for optimal delivery.Possible associated factors may also include: use of a non-qualified viscoelastic or bss in the delivery system.Material properties of non-qualified ophthalmic viscoelastic devices (ovds) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.Excessive delay between device preparation and subsequent delivery resulting in the potential for haptic unfolding.Use of the delivery system at operating room temperatures outside of the recommended range of 18 °c (64 °f) to 23 °c (73 °f).Ovd should be allowed to come to operating room temperature over a 20 minute timeframe prior to use.Any of the above factors alone, or in combination, may lead to an event such as reported.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 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: 23450028
• Report Number: 9612169-2025-02189
• Device Sequence Number: 8345334
• Product Code: MJP
• UDI-Device Identifier: 00380658458638
• UDI-Public: (01)00380658458638(17)280916(11)240918(10)25920188
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 25920188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 82 YR
• Patient Sex: Female