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 Prime (1492); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A nonhealth care professional reported that after the intraocular lens (iol)implantation surgery, the plunger started to curve and then sliced the haptic off.There was no patient contact.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was returned for analysis and broken pin stop was observed.The device was returned in an opened blister.The lock-out assembly is removed.The pin stop is broken and is stuck in the lens bay door in the pin stop designated area.Solution is dried in the device.The device was received activated; the plunger is advanced outside of the device and is slightly bent.The lens is crushed over the broken pin stop.The product did not meet specifications.The lens pin stop was found to be broken and stuck in the lens bay door in the pin stop designated area.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: 23671394
• Report Number: 9612169-2025-02375
• Device Sequence Number: 9753792
• Product Code: HQL
• UDI-Device Identifier: 00380652397049
• UDI-Public: (01)00380652397049(17)280421(11)240423(10)25844134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/17/2026

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: 25844134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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: VISCOAT.
• Patient Sex: Unknown