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 Code	Eye Burn (2523)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as the device is not an implantable.Section d6b: if explanted, give date: not applicable, as the device is not an implantable.Device evaluation: a field service engineer (fse) visited site and performed a preventative maintenance (pm) and found no issues.Unit tested and passed jjsv specifications.A clinical specialist also visited site on (b)(6) 2025 and worked with surgeon and had no issues with phaco.Section e1 phone number (b)(6).Manufacturing records review: a review of records including device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that patient had a phaco burn.No additional information was provided.Note: this report is 1 of 5.

• 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: 22868439
• Report Number: 3012236936-2025-000223
• Device Sequence Number: 18054915
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/21/2025

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
• 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: 07/28/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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, SLEEVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown