MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. VERITAS VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	VRT680300
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu (b)(4).(general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable.Veritas console is not an implantable device.Section d6b - explant date: not applicable.Veritas console is not an implantable device; therefore, not explanted.Section e1 - first/given name: unknown, as information was requested but not provided.Section e1 - last name: unknown, as information was requested but not provided.Section e1 - email address: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6) device evaluation: the field service engineer (fse) visited site and reported that the gas forced infusion was low and adjusted it and performed several tests.System meets the product specifications.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that low pressure error 160 gas forced infusion (gfi) was observed.Patient involvement was reported.Through follow-up we learned that the issue occurred during the procedure.Patient is fine.No further information was provided.

• Brand Name: VERITAS VISION SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24954741
• Report Number: 3012236936-2026-000090
• Device Sequence Number: 20153530
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K203060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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 Model Number: VRT680300
• Device Catalogue Number: VRT680300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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