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

Model Number NGP680301

Device Problem Restricted Flow rate (1248)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

A j&j specialist spoke to the surgeon and identified the phaco settings required modifications.The bottle was raised, and the vacuum settings were decreased to resolve chamber issues.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 cataract patient experienced a capsular rupture requiring a vitrectomy procedure.A description from the surgery center indicated the posterior bag had moved resulting in the broken capsule.The anterior chamber fluctuated during phaco segment and the posterior bag was captured, resulting in a hole that required an anterior vitrectomy.A johnson & johnson (j&j) representative was at the surgery center at the time of the event.The j&j representative adjusted the surgeon settings to resolve chamber instability.The bottle was raised, and the vacuum settings were decreased.The surgery center did not request a service call.The patient outcome is well.

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 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: 8609203
• MDR Text Key: 145017038
• Report Number: 3006695864-2019-00376
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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