MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL; ADVANCE LINEAR FOOTPEDAL

Model Number	NGP680703
Medical Device Problem Codes	Accessory Incompatible (1004); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown as it was not provided.(b)(6).Manufacturer year: 2016.The system was evaluated by a field service engineer.All modes of operation and calibrations were verified, and no failures were detected with the phacoemulsification console.The field service engineer found the footpedal switch was not working and the footpedal was replaced.The unit complied with all factory settings.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract extraction procedure, the surgery center reported a posterior capsular rupture in the patient¿s operative eye requiring an anterior vitrectomy procedure when using the footpedal accessory and signature pro console.A brief description from the surgery center reported there was unstable chamber during procedure and the footpedal was stuck and not working properly.It was reported the patient outcome is well.Visual acuity pre and post measurements: visual acuity pre-operative: 0,3; visual acutiy post-operative: 0,6.This report is for the footpedal equipment.A separate report will be submitted for the phacoemulsification console.
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 (b)(4) and capa-010215.

• Brand Name: WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL
• Common Device Name: ADVANCE LINEAR FOOTPEDAL
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 8276086
• Report Number: 3006695864-2019-00055
• Device Sequence Number: 19347023
• Product Code: HQC
• UDI-Device Identifier: 05050474596122
• UDI-Public: (01)05050474596122
• Combination Product (Y/N): Y
• Initial Reporter Country: ES
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NGP680703
• Device Catalogue Number: NGP680703
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHACOEMULSIFICATION CONSOLE SN: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005