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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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 intraocular lens (iol) implantation procedure, they noticed that the tip of the device was crooked.They were unable to use the device.The surgery was completed with a replacement device.There was no patient injury.Based on the new information received on 07-jan-2026: three additional devices of the same model and diopter value had the same crooked-tip issue and were unusable.
Additional Manufacturer Narrative
Additional information provided in sections 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 loose in the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been advanced outside of the device and is advanced over the intraocular lens (iol).The iol is advanced into the nozzle entry and is damaged.The plunger tip is bent.The product investigation could not identify the root cause for the reported complaint "tip was crooked and unable to use".Plunger tip was observed to be bent.All plungers are 100% inspected as per approved manufacturing procedures at the vendor site and the observed plunger damage would not meet the release criteria.The product was subject to handling.We are unable to confirm the device preparation.Plunger override was observed on the returned product.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 devices (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 (> 23°c / 73° f) 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 plunger override event.Based on this investigation findings, we are unable to verify if the product contributed to the event.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: 24232564
• Report Number: 9612169-2026-00212
• Device Sequence Number: 18446796
• Product Code: HQL
• UDI-Device Identifier: 00380652397285
• UDI-Public: (01)00380652397285(17)290930(11)251002(10)26111062
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 26111062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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
• Patient Sex: Unknown