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

Catalog Number	8065998329
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an inaccurate measurement resulted in the incorrect intraocular lens being implanted at the wrong axis in the patient's right eye, after intraocular lens implantation 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.Based on the assessment, the product met release criteria.Service history was reviewed for the system.A service record relevant to the reported complaint was found.Service record was opened to address the reported event.An alcon representative performed an on-site assessment and was unable to confirm or replicate the reported event.The system was then tested per the service test procedure and found to meet company specifications.Based on the information obtained, the root cause of the reported event is inconclusive.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: 19467390
• Report Number: 2028159-2024-00827
• Device Sequence Number: 7498595
• Product Code: NCF
• UDI-Device Identifier: 00380659983290
• UDI-Public: (01)00380659983290(17)310227(11)210301(10)13TKKV
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/10/2024

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: Other
• Device Catalogue Number: 8065998329
• Device Lot Number: 13TKKV
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 09/10/2024
• Date Device Manufactured: 03/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ORA SYSTEM WITH VERIFEYE MESSAGING, CART
• Patient Age: 74 YR
• Patient Sex: Female