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

Model Number	NGP0023
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Dull, Blunt (2407)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Customer had an issue with the vitrector, it did not cut or was not working properly.Physician was trying to remove the cortex from the capsule bag because there was a slight tear.The vitrector would not aspirate or cut.They did not use a new one.Physician decided to just insert the lens and move on with remaining cortex.Case was completed with no patient adverse effects.No further information was provided.
Additional Manufacturer Narrative
This case was downgraded and is no longer considered reportable since the vitrector was found not to be the cause of the posterior capsule tear.Our subject matter expert concluded that the complaint involving the vitrector happened only after the tear had already occurred.No additional details will be given regarding this case.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 20397940
• Report Number: 3012236936-2024-000270
• Device Sequence Number: 19677640
• Product Code: MLZ
• UDI-Device Identifier: 05050474534100
• UDI-Public: (01)05050474534100(17)260117(10)60428266
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 01/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2026
• Device Model Number: NGP0023
• Device Catalogue Number: NGP0023
• Device Lot Number: 60428266
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose