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, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Corneal Edema (1791); Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Eye Pain (4467); No Clinical Signs, Symptoms or Conditions (4582); Eye Irritation (4803)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported system provided calculations which were off in the left eye of the patient as a result lens power came out wrong after refractive surgery, post the patient experienced glares, corneal edema, mild astigmatism, dryness, itchiness, eye pain.Further, the intraocular lens was explanted.There was no patient harm and medical intervention reported additionally.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non healthcare professional reported system provided calculations which were off in the left eye of the patient as a result lens power came out wrong after refractive surgery.There was no patient harm and medical intervention reported additionally.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6., and h.11.A manufacturing device history record (dhr) 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.There were no service records (relevant to the reported event), found.However, the system was last serviced prior to the reported event per service record.Based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 24379018
• Report Number: 2028159-2026-00201
• Device Sequence Number: 21384547
• Product Code: NCF
• UDI-Device Identifier: 00380657530939
• UDI-Public: (01)00380657530939(17)290601(11)190604(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

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: 8065753093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 05/12/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASA 325 MG.; ATORVASTATIN.; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL.; CLOPIDOGREL.; CYCLOBENZAPRINE.; DULOXETINE DR.; GABAPENTIN.; HYDROCHLOROTHIAZIDE.; KETOROLAC.; LAL +24.0 REPLACEMENT LENS. SN: (B)(6).; LEVOTHYROXINE SODIUM.; MELOXICAM.; METFORMIN ER.; METOPROLOL TARTRATE.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MOUNJARO.; MOXIFLOXACIN.; OMEGA 3.; OMEPRAZOLE.; PREDNISOLONE ACETATE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; VITAMIN D.; VITAMIN K2.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female