MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon TruPlus Toric Aspheric UV Absorbing IOL w/ AutonoMe Delivery System; Lens, Intraocular, Toric Optics

Model Number	RECAT5
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that, during intraocular lens implantation surgery, a greasy spot was observed on the lens.Additionally, the plunger was found to be rougher/tougher.The lens was inserted.Additional information has been requested but is 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 TruPlus Toric Aspheric UV Absorbing IOL w/ AutonoMe Delivery System
• Common Device Name: Lens, Intraocular, Toric Optics
• 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: 50775793
• Report Number: 9612169-2026-02084
• Device Sequence Number: 9424824
• Product Code: MJP
• UDI-Device Identifier: 00380658536480
• UDI-Public: (01)00380658536480(17)301026(11)251028(10)26134791
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/15/2026

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: RECAT5
• Device Catalogue Number: RECAT5.210
• Device Lot Number: 26134791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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