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

Model Number	LFD-2000
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
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 nr-0148919 and capa-010215.

• Brand Name: LIPIFLOW ACTIVATOR II
• Common Device Name: LIPIFLOW
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8678608
• Report Number: 3008169506-2019-00001
• Device Sequence Number: 13934345
• Product Code: ORZ
• UDI-Device Identifier: 00859623006315
• UDI-Public: (01)00859623006315(17)181130(10)1821220005
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/13/2019; 10/25/2020
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/08/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005