MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center ORA System with VerifEye Messaging; Aberrometer, Ophthalmic

Catalog Number	8065998329
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction

• Brand Name: ORA System with VerifEye Messaging
• Common Device Name: Aberrometer, Ophthalmic
• Manufacturer (Section D): Alcon Research, LLC - Irvine Technology Center; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): Alcon Research, LLC - Irvine Technology Center; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50232378
• Report Number: 2028159-2026-01276
• Device Sequence Number: 18710396
• Product Code: NCF
• UDI-Device Identifier: 00380659983290
• UDI-Public: (01)00380659983290(17)330916(11)230919(10)16720H
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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 Catalogue Number: 8065998329
• Device Lot Number: 16720H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 09/19/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown