MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LIPIFLOW ACTIVATOR II

Model Number LFD-2000

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the lipiflow activator, lot no.1821220005 was returned to evaluation.A visual evaluation was performed.Activator lot# 1821220005 was returned outside its primary seal package.The primary package was received opened, but seal markings were visible on the tyvek pouch.No damage on the device was observed, however debris and fiber were observed on the activator.Unable to determine the exact cause.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A surgery center reported observed a lipiflow activator not sealed upon opening the outer box.A description from the surgery center indicated that 1 of 10 lipiflow activators that were individually packaged was not sealed and was at the bottom of the box.The remaining 9 activators were sealed.The unsealed package was discovered prior to use and during handling.No patient contact or patient injury reported.

Manufacturer Narrative

Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the activator lot# 1821220005.All devices met material, assembly and performance specifications at the time of product released.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: LIPIFLOW ACTIVATOR II
• Type of Device: LIPIFLOW
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8678608
• MDR Text Key: 147347483
• Report Number: 3008169506-2019-00001
• Device Sequence Number: 1
• Product Code: ORZ
• UDI-Device Identifier: 00859623006315
• UDI-Public: (01)00859623006315(17)181130(10)1821220005
• Combination Product (y/n): Y
• PMA/PMN Number: K161357
• 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: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: LFD-2000
• Device Catalogue Number: 220150
• Device Lot Number: 1821220005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• 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