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

Model Number NGP680300

Device Problems Failure to Deliver Energy (1211); Restricted Flow rate (1248); No Pressure (2994)

Patient Problem No Code Available (3191)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.(b)(6).(b)(4).Manufacturer year 2010.Device evaluation: the whitestar signature system was examined and tested at the customer location by an jjsv field service specialist (fss).The fss completed system checks, he checked handpieces used.No problems found.He will provide support for next treatment day.System meeting j&j vision specifications.A review of the device history record, labeling, 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 Description

During a cataract procedure using a whitestar signature system, there was no phaco power resulting in an aborted procedure.A description from the surgery center indicated the system had passed the priming stage; when the surgeon applied the handpiece in the right operative eye, there was no flow, no vibration and no phaco power.The surgery center attempted to replace the handpiece to resolve the issue, but the same problem occurred.The procedure was aborted, and the patient has sutures placed to close the opening that was made for the cataract procedure.No additional information was provided.

Manufacturer Narrative

New information received needs to be submitted with a supplemental report.Device manufacture date : 04 february 2010.All pertinent information available to johnson and 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 SYSTEM
• 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: 9375416
• MDR Text Key: 168459704
• Report Number: 3006695864-2019-00932
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

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
• Device Operator: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: NGP680300
• 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
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 10/25/2020
• Supplement Dates FDA Received: 01/10/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDPIECE
• Patient Outcome(s): Required Intervention