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

Model Number	CNA0T0
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.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 non-healthcare professional reported that during the intraocular lens (iol) implant procedure, the back haptic bent and twisted.The procedure was completed.Additional information has been requested and received stating that in the surgeon¿s opinion the plunger was to far to the right and caused the trailing haptic to bend and twist.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis, and the reported complaint was observed.The device was received inside a non-company pouch.Solution is dried in the device.The lock-out assembly has been removed.The plunger and the lens have been advanced into the mid-nozzle.The plunger is advanced under the intraocular lens (iol), the iol and the haptics are misfolded.We are unable to determine the root cause for the reported complaint "back haptic bent and twisted".Plunger underride was observed.Plunger underride 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 ovds 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 or become ¿stuck¿ in the device allowing the plunger to underride the lens.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.If ovd has not been allowed to come to operating room temperature over a 20-minute timeframe prior to use.Colder temperatures can increase the ovd viscosity, creating greater resistance during iol delivery, causing potential unsuccessful delivery outcomes.Any of the above listed causes alone, or in combination, may create the reported 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 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: 24539876
• Report Number: 9612169-2026-00524
• Device Sequence Number: 13018402
• Product Code: HQL
• UDI-Device Identifier: 00380652393737
• UDI-Public: (01)00380652393737(17)281028(11)251030(10)26144442
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 26144442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/07/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown