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 Keratitis (1944); Red Eye(s) (2038); Corneal Infiltrates (2231)

Event Date 05/11/2019

Event Type  Injury  

Manufacturer Narrative

Phone number: (b)(6).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.Manufacturing date requested but not available at the time of this report.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

It was reported that patient was treated with lipiflow system.Post treatment, the patient¿s eye was red, felt burn and under slit lamp examination the cornea was punctate.It was reported that prior to treatment, doctor dropped the anesthesia eyedrops and the patient¿s ocular surface was not good because of meibomian gland dysfunction (mgd) disease.Physician prescribed steroid drug, artificial eyedrop to patient for relief the symptom.It was reported that patient recovered.

Manufacturer Narrative

Additional information: the manufacturing site reported that the manufacturing date for the device is 12/2013.Conclusions codes 4310 and 18.The lipiflow thermal pulsation system contraindications state to not use the device in patients with ocular surface abnormality that may compromise corneal integrity and/or active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months as its use may cause injury.

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 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: 8756340
• MDR Text Key: 149922769
• Report Number: 3008169506-2019-00003
• 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: foreign,health professional,u
• 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: 07/02/2019
• 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
• Patient Outcome(s): Required Intervention