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	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, it was noted that trailing haptic was folded wrongly with no patient contact.The procedure was completed on the same day.Additional information has been requested.
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., h.11.The product was not returned for analysis.Only photo was returned.The reported complaint was not observed on the returned photo.The returned photo shows activated company specific device.The plunger and the lens are advanced at the mid nozzle area.The leading haptic appears to be extended straight.The plunger appears to be positioned at the trailing optic edge and the trailing haptic appears to be folded onto the optic in a correct position.The complainant indicates the use of another company viscoelastic which is not qualified for use with the associated product.No root cause identified as the reported complaint "trailing haptic folded wrongly " was not observed.Based on our observations of the returned photo, the position of the trailing haptic is correct.The leading haptic was observed to be extended straight.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 viscosurgical device (ovd) 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 degree celsius (64 degree fahrenheit) to 23 degree celsius (73 degree fahrenheit).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 straight leading haptic.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: 22701384
• Report Number: 9612169-2025-01541
• Device Sequence Number: 8986564
• Product Code: MJP
• UDI-Device Identifier: 00380652399418
• UDI-Public: (01)00380652399418(17)281210(11)241212(10)25955914
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: 25955914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 12/12/2024
• 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: ZEISS COMBI VISC.
• Patient Sex: Unknown