MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI; VITRECTOMY, INSTRUMENT CUTTER

Model Number	NGP0020
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as the vitrectomy cutter is not an implantable device.Section d6b: if explanted, give date: not applicable, as the vitrectomy cutter is not an implantable device.Section h3: the vitrectomy cutter 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 & johnson surgical vision, inc has been submitted.
Event or Problem Description
Customer reported that their surgical adjunct device malfunctioned during a cataract surgery, resulting in a posterior capsule tear in patient's oculus dexter (od) right eye.The device's tip was found to be non-functional upon testing, necessitating the use of a new device to complete the procedure.A vitrectomy was performed.The intraocular ar40e lens with serial number (b)(6) was implanted.The patient is reported to be fine post-surgery.No further information was provided.
Additional Manufacturer Narrative
The case was downgraded as the vitrectomy cutter is used for planned vitrectomy which resulted from a capsule tear during cataract surgery.No further information will be provided for this case.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI
• 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: 21339489
• Report Number: 3012236936-2025-000033
• Device Sequence Number: 8550511
• Product Code: MLZ
• UDI-Device Identifier: 05050474534094
• UDI-Public: (01)05050474534094(17)270116(10)60528035
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/05/2025

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 Model Number: NGP0020
• Device Catalogue Number: NGP0020
• Device Lot Number: 60528035
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander