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	Capsular Bag Tear (2639)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an operating room procedure involving phacoemulsification with the vrt ai tubing, a rupture of the capsule occurred.As a result, a vitrectomy will be performed on the patient, and an enclavation lens will be implanted.The patient¿s current status and details regarding recovery or further medical attention remain unknown.No additional information was received.This report is for the verita vision system.Different reports are being submitted for the other suspect products.
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable.The veritas vision system is not an implantable device.Section d6b - explant date: not applicable.The veritas vision system is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.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: 23649843
• Report Number: 3012236936-2025-000301
• Device Sequence Number: 10055332
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 11/01/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown