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

Model Number	CCA0T0
Medical Device Problem Codes	Failure to Deliver (2338); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure the pusher was above the lens and the lens did not come out of the delivery system.There was a patient contact, and the lens did not deploy in the incision.Additional information has been received that the plunger went above the lens and the lens did not come out of the delivery system.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be observed.Iol was not returned.Only the device was returned.The device was returned in an opened 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.No damage observed.Iol was not returned.The product investigation could not identify the root cause for the reported complaint the pusher was above the lens, lens stuck/would not advance" as the lens was not returned.Only the device was returned for evaluation.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.Plunger override/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 override/underride the lens.If the operating room temperature is too high (more than 23 degreec or 73degreef) 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 ASPHERIC UV ABSORBING IOL WITH 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: 22668868
• Report Number: 9612169-2025-01514
• Device Sequence Number: 12624838
• Product Code: HQL
• UDI-Device Identifier: 00380652397315
• UDI-Public: (01)00380652397315(17)271203(11)231205(10)25759101
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: CCA0T0
• Device Lot Number: 25759101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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 VISCOSURGICAL.
• Patient Sex: Unknown