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	RECAT4
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• 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: 50094444
• Report Number: 9612169-2026-01740
• Device Sequence Number: 18721342
• Product Code: MJP
• UDI-Device Identifier: 00380658536008
• UDI-Public: (01)00380658536008(17)301127(11)251129(10)26164776
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: RECAT4
• Device Catalogue Number: RECAT4.215
• Device Lot Number: 26164776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 11/29/2025
• 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