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

Model Number	CNA0T4
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A health care professional reported that during loading the trailing haptic caught behind.The lens could not be implanted due to damage.The surgery was completed on the same day using a backup lens.
Additional Manufacturer Narrative
Correction information was provided in h.6.On initial medical device report (mdr) the fda patient codes of e2401 and fda health impact codes f24 were submitted.It should have been e2403 and f26.The product was not returned for analysis.Only photo was returned.Plunger underride was observed on the returned photo.Photo provided shows an activated company device.The plunger appears to be advanced into the nozzle tip and appears to be advanced under the intraocular lens (iol).The iol appears to be advanced into the nozzle tip and is crushed.We are unable to determine the root cause for the reported complaint "trailing haptic caught behind".The product was not returned for analysis.Plunger underride was observed on the returned photo.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 opthalmic viscosurgical 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 or become "stuck" in the device allowing the plunger to underride the lens.If the operating room temperature is too high (greater than 23 degrees centigrade / 73 degrees fahrenheit) 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.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 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: 24334161
• Report Number: 9612169-2026-00339
• Device Sequence Number: 11981089
• Product Code: MJP
• UDI-Device Identifier: 00380652399289
• UDI-Public: (01)00380652399289(17)280920(11)240922(10)25921207
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: CNA0T4
• Device Lot Number: 25921207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 09/22/2024
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• Patient Sex: Unknown