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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the iol was observed with a chunk missing after it was injected through the injector.The originally scheduled procedure was completed, and the lens was left inside the eye and centered.There was no patient harm.Additional information was requested but was not available at the time of this report.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50945902
• Report Number: 9612169-2026-02242
• Device Sequence Number: 9534628
• Product Code: HQL
• UDI-Device Identifier: 00380652397384
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 09/30/2026

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: 26252948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 05/21/2026
• 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
• Patient Age: 71 YR
• Patient Sex: Female