MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LIPIFLOW THERMAL PULSATION SYSTEM CONSOLE

Model Number LFTP-1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Red Eye(s) (2038)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

Serial #: serial number is unknown as it was not provided.Udi #: unique identifier is unknown as serial number was not provided.Manufacture date: manufacturer date is unknown as serial number was not provided.Device evaluated by mfr: 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

Customer reported that one of their patients had a bad reaction after the treatment with the lipiflow.Dr.(b)(6) described the patient as having very red eyes, pain and possible herpetic infection.Dr.(b)(6) prescribed her lotemax.At a follow up visit, patient is still experiencing pain and redness.The patient has a history of shingles.

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 THERMAL PULSATION SYSTEM CONSOLE
• Type of Device: LIPIFLOW
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8833980
• MDR Text Key: 152498043
• Report Number: 3008169506-2019-00005
• Device Sequence Number: 1
• Product Code: ORZ
• UDI-Public: (01)(10)UNKNOWN
• 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
• 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: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LFTP-1000
• 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
• Treatment: ACTIVATORS
• Patient Outcome(s): Required Intervention