MAUDE Adverse Event Report: Johnson & Johnson Surgical Vision, Inc. VERITAS VISION SYSTEM; Unit, Phacofragmentation

Model Number	VRT680300
Medical Device Problem Codes	Failure to Prime (1492); Suction Problem (2170); Pressure Problem (3012); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction

• 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 ; +1(714)247-8552
• MDR Report Key: 50091987
• Report Number: 3012236936-2026-000203
• Device Sequence Number: 9913296
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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