MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. DISPOSABLE 23GA VITRECTOMY CUTTER; VITRECTOMY, INSTRUMENT CUTTER

Model Number	NGP0023
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2 a3, a4 and a5: unknown/ not provided.Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device 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 and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that doctor had an unplanned anterior vitrectomy while using the veritas system.It was also reported that the 3g vitrectomy cutter would not cut.They had to convert to another company's system for the vitrectomy to complete the case.This added about 20 minutes to the case.No additional information was provided.This report is report against the vitrectomy cutter.A separate report will be filed against the veritas system.

• Brand Name: DISPOSABLE 23GA VITRECTOMY CUTTER
• Common Device Name: VITRECTOMY, INSTRUMENT CUTTER
• 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: 20218323
• Report Number: 3012236936-2024-000251
• Device Sequence Number: 7877069
• Product Code: MLZ
• UDI-Device Identifier: 05050474534100
• UDI-Public: (01)05050474534100(17)270110(10)60528139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081681
• 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): 09/13/2024

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: NGP0023
• Device Catalogue Number: NGP0023
• Device Lot Number: 60528139
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERITAS SN: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose