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 Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the surgeon attempted to insert the lens into the patient¿s eye, but the front haptic came out before the lens could be inserted.There was patient contact however, the lens remained halfway in the cartridge and was never fully implanted.Additional information was received by stating, there was no patient harm.
Additional Manufacturer Narrative
Additional information has been 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 returned 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 advanced at the wound guard and is advanced under the iol (intraocular lens).The iol is advanced into the nozzle tip and is crushed.Part of the damaged leading haptic is protruding from the nozzle tip.We are unable to determine the root cause for the reported complaint "front haptic came out before actually being able to insert".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 (ophthalmic viscosurgical device) 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 manufacturing batch record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 24982982
• Report Number: 9612169-2026-00955
• Device Sequence Number: 10451344
• Product Code: HQL
• UDI-Device Identifier: 00380652397346
• UDI-Public: (01)00380652397346(17)300114(11)260116(10)26175247
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/10/2026

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: CCA0T0
• Device Lot Number: 26175247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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 Age: 69 YR
• Patient Sex: Male