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

Catalog Number	8065753093
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that the system was measuring spherical but not measuring cylinder.The selection for astigmatism did not exist for the patient.There was no red fixation light on the screen during unknown procedure.
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.The company representative was unable to replicate the reported event.The nonconforming system components was replaced to address the issue.The system was tested and found to meet product specifications.The root cause of the reported event can be attributed to a non-conforming system components.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.The company representative was unable to replicate the reported event.The nonconforming system components was replaced to address the issue.The system was tested and found to meet product specifications.The system was received for testing on this investigation.Visual inspection was performed.Sample testing could not be performed because the sample was damaged upon receipt.However, it is unclear if the system was damaged at the customer site or during transit.Based on the information available, the reported event is inconclusive.Based on the information available, the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).

• Brand Name: ORA SYSTEM WITH VERIFEYE MESSAGING, CART
• 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: 18695227
• Report Number: 2028159-2024-00224
• Device Sequence Number: 7070675
• Product Code: NCF
• UDI-Device Identifier: 00380657530939
• UDI-Public: (01)00380657530939(17)320724(11)220727(10)14XLHW
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 08/28/2024

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: Health Professional
• Device Catalogue Number: 8065753093
• Device Lot Number: 14XLHW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 04/01/2024; 08/01/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/23/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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
• Patient Sex: Unknown