MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE PRO CONSOLE; PHACOFRAGMENTATION UNIT

Model Number NGP680301

Device Problems Restricted Flow rate (1248); Inaccurate Delivery (2339)

Patient Problem Eye Burn (2523)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer year 2016.The system was evaluated by a field service engineer.The field service found no issues with the unit.A field service checklist was performed.All modes of operation and calibrations were verified.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 Description

During a cataract extraction procedure, a corneal burn occurred in the patient¿s operative eye.The surgeon reported that while conducting the phaco cataract removal, the aspiration seemed to stop working creating a corneal burn.The surgeon had to use multiple sutures to close the wound/incision.The procedure was completed without any complications and the lens was implanted.The surgeon requested service on the console as there is too much irrigation during the fluidics delivery.

Manufacturer Narrative

Additional: in initial report, the manufacturer year was only provided, however the full date is 06/16/2016.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

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: WHITESTAR SIGNATURE PRO CONSOLE
• Type of Device: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8364799
• MDR Text Key: 136971962
• Report Number: 3006695864-2019-00155
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention