MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during cataract surgery with intraocular lens (iol) implantation surgery, the iol plunger incorrectly positioned the lens within the narrow section of the cartridge.This caused pinching and resulted in detachment of the iol haptic element as it exited the device.The physician replaced the damaged lens with an identical iol of the same diopter power.The patient was not involved.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned, the haptic is observed to be broken.Photos provided show pic 2) an activated company device.The plunger appears to be fully advanced outside the nozzle tip.Pic 3) shows an intraocular lens (iol) in a blister tray.One haptic appears to be broken/torn and is visible under the other haptic, the other haptic appears to be damaged.The product investigation could not identify the root cause for the reported complaint "iol plunger incorrectly positioned, led to pinching and detachment of the iol haptic" as the product was not returned.Photos were returned; however the iol was observed to be outside of the device.The iol was observed to be broken in the returned photos.Broken haptics may occur: if the lens has become misaligned in the lens bay during the manufacturing process.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ophthalmic visco surgical device (ovd) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.The directions for use (dfu) instructs: ""visually inspect the lens to determine the position of the leading and trailing haptics (refer to figure 7).Verify that the plunger is in contact with the trailing optic edge." the product history records confirm that the product met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 23908488
• Report Number: 9612169-2025-02618
• Device Sequence Number: 10024206
• Product Code: HQL
• UDI-Device Identifier: 00380652393706
• UDI-Public: (01)00380652393706(17)280511(11)250513(10)26038425
• Combination Product (Y/N): N
• Initial Reporter Country: BO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: CNA0T0
• Device Lot Number: 26038425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 05/13/2025
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown