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	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown, as information was requested but not provided.Section e1: first/given name: unknown.Section e1: last name: unknown.Section e1: email address: unknown.Section e1: telephone number: (b)(6).Device evaluation: the gfi pressure output was unstable and the field service engineer (fse) performed a pneumatic assy replacement.The fluidics firmware was updated and the touchscreen was fixed.System performing to specifications.A review of the device history record and complaint trending will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the error e160 indicated excessively low gas forced infusion (gfi) pressure occurred during the procedure.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: 24945585
• Report Number: 3012236936-2026-000085
• Device Sequence Number: 9890261
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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