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	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of records related to the device including labeling, complaint trending, and risk documentation was performed.No related non-conformity or deviations were issued during manufacturing the activator lot# 1913320013.Product 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.
Event or Problem Description
It was reported that a few days after lipiflow treatment the patient developed a chalazion in the right eye.The eye was red and sore.Symptoms started to develop in the left eye as well afterward.There were no issues during the treatment and she had none visible on the day of treatment.No treatment at the time was given.During follow up it was reported that patient started using an antibiotic drop.It was also reported that the patient had styes and not chalazions.Note: this report is for the right eye.A report for the left eye is being submitted for separately.
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 (b)(4) and capa-010215.

• Brand Name: LIPIFLOW ACTIVATOR II
• Common Device Name: LIPIFLOW ACTIVATOR II
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9146243
• Report Number: 3008169506-2019-00006
• Device Sequence Number: 16851789
• Product Code: ORZ
• UDI-Device Identifier: 00859623006315
• UDI-Public: (01)00859623006315(17)230513(10)1913320013
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K161357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020
• 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: 05/13/2023
• Device Model Number: LFD-2000
• Device Catalogue Number: 220150
• 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: 09/05/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/10/2020
• 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
• Date Report Sent to FDA: 01/01/2005