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

Model Number	VRT680300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Eye Burn (2523)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown/ not provided.Section b3 date of event: unknown section d6a: if implanted, give date: not applicable, as the system is not an implantable device.Section d6b: if explanted, give date: not applicable, as the system is not an implantable device.Section h3: our field service engineer (fse) was onsite for a system check.No problem was found.System performing to 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 & johnson surgical vision, inc has been submitted.
Event or Problem Description
Customer reported wound burns and corneal edema affecting multiple patients while using the veritas system.No further information was provided.Note: this is report 1 of 4.
Additional Manufacturer Narrative
Corrected data: based on further review of the complaint file, it was noted that the device manufacturer information was not included on the initial medwatch report.The following sections have been updated accordingly.Section h4.Device manufacturer date: aug 27, 2021 section h6.Investigation findings: 114 - operational problem identified section h6.Investigation conclusions: 19 - cause traced to user.Our clinical applications specialist provided instructions.It was determined to be user error.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• 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: 23372387
• Report Number: 3012236936-2025-000274
• Device Sequence Number: 18672493
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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?: No
• 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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TUBING, TIP, HANDPIECE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown