MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER ORA SYSTEM WITH VERIFEYE MESSAGING; ABERROMETER, OPHTHALMIC

Catalog Number	8065998328
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported system provided inconsistent measurements resulted in an intraocular lens exchange in the unknown eye of the patient during cataract surgery.
Additional Manufacturer Narrative
H.3., h.6.: 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).
Additional Manufacturer Narrative
A manufacturing device history record review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.The company representative was able to replicate the reported event.The nonconforming component was replaced to address the issue.The system was tested and found to meet product specifications.The root cause of the reported event is attributed to non-conforming component.The manufacturer internal reference number is: (b)(4).

• 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 ; 8007579780
• MDR Report Key: 21710560
• Report Number: 2028159-2025-00385
• Device Sequence Number: 18629999
• Product Code: NCF
• UDI-Device Identifier: 00380659983283
• UDI-Public: (01)00380659983283(17)290628(11)190701(10)128E2V
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065998328
• Device Lot Number: 128E2V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/22/2025
• Date Device Manufactured: 07/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown