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

Model Number	CNA0T0
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
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 an intraocular lens (iol) implant procedure, viscoelastic was placed as indicated for assembly and lens was advanced.It was evidenced that the plunger was on the optic and the haptic was screwed.Doctor examines it under a microscope and decides to remove the lens from the injector.A paracentral mark was found on the optic related to poor positioning of the plunger and haptic.The lens had no contact with the patient.Doctor requested a new lens of same model and diopter, which was implanted without complications.There was no impact to the patient.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis, and the reported complaint could not be observed.Intra ocular lens (iol) was returned outside of the device.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.Stress observed on the nozzle tip.The lens was returned outside of the device adhered to the lever with a sticky tape.Solution is dried on the iol.The optic is scratched or marked - rejectable.No damage to haptics observed.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The product investigation could not identify the root cause for the reported complaint plunger is on the optic and the haptic is screwed, mark on optic as the lens was returned outside of the device.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.Plunger override 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 viscosurgical device(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 override the lens.If the operating room temperature is too high (greater than 23 degree centigrade / 73 degree 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.In addition to the above, damage was observed to the tip of the nozzle.The observed damage typically occurs if there is a lack of viscoelastic between the lens and the nozzle lumen and or if the plunger is not positioned correctly at the trailing optic edge for advancement.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the nozzle causing damage or become stuck.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: 22871000
• Report Number: 9612169-2025-01689
• Device Sequence Number: 9091845
• Product Code: HQL
• UDI-Device Identifier: 00380652393812
• UDI-Public: (01)00380652393812(17)280105(11)250106(10)25964292
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 10/22/2025

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: CNA0T0
• Device Lot Number: 25964292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/02/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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; UNSPECIFIED VISCOELASTIC
• Patient Age: 80 YR
• Patient Sex: Female