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

Model Number	LFD-2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that patient had treatment with lipiflow system for dry eye on (b)(6) 2018 and presented on (b)(6) 2018 with hordeolum in the left eye.Patient was treated with antibiotics.It was reported that activator device was discarded.
Additional Manufacturer Narrative
The review of the device history record (dhr) for the device showed that there were no related non-conformity or deviations issued during manufacturing of activator lot# 1806701.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.Based on the investigation no problem was found.All pertinent information available to abbott medical optics 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; santa ana CA
• MDR Report Key: 7999502
• Report Number: 3008169506-2018-00102
• Device Sequence Number: 13503663
• Product Code: ORZ
• UDI-Device Identifier: 20859623006333
• UDI-Public: (01)20859623006333(17)220308(10)1806701
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2022
• Device Model Number: LFD-2000
• Device Lot Number: 1806701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/26/2018; 10/25/2020
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/20/2018; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Date Report Sent to FDA: 01/01/2005