MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC WHITE STAR HIGH SPEED VIT CUTTER; DISPOSABLE VITRECTOMY CUTTER

Model Number	NGP0025
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A surgery center reported mislabeling on two disposable vitrectomy cutters.A brief description from the surgery center indicated they ordered size 25-gauge disposable vitrectomy cutters but upon opening the package, the actual vitrectomy cutter had size 20-gauge engraved on the device.No indication of patient contact.This is 1 of 2 reports.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 08/10/2018.Device returned to manufacturer? yes.Device evaluation: the disposable vitrectomy cutter was returned within its original packaging confirming the reported lot number of 60084881.A visual inspection of the returned device showed both pouches were opened; no biological fluids or indications that the item was used were observed.Failure mode of mislabeled sample was confirmed as a 20ga vit cutter was returned along with as 25ga labeling.The reported mislabeling issue was confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Johnson & johnson surgical vision (jjsv) has voluntarily initiated a voluntary recall because a possibility exists that due to a packaging error, a 20 gauge vitrectomy cutter may be found in a 25 gauge package.Use of a vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.Corrective and preventive actions will be implemented as required.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: WHITE STAR HIGH SPEED VIT CUTTER
• Common Device Name: DISPOSABLE VITRECTOMY CUTTER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7767478
• Report Number: 3006695864-2018-01653
• Device Sequence Number: 19310214
• Product Code: MLZ
• UDI-Device Identifier: 05050474534117
• UDI-Public: (01)05050474534117(17)200905(10)60084881
• Combination Product (Y/N): Y
• PMA/510(K) Number: K081681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/02/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: NGP0025
• Device Catalogue Number: NGP0025
• Device Lot Number: 60084881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/26/2018; 09/19/2018; 10/25/2020
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/18/2018; 10/05/2018; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2018-5
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005