LIPIFLOW THERMAL PULSATION SYSTEM CONSOLE
Received Jul 2, 2019 · Event occurred May 11, 2019
Report 3008169506-2019-00003 · MDR key 8756340
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Keratitis
- Red Eye(s)
- Corneal Infiltrates
- Keratitis
- Red Eye(s)
- Corneal Infiltrates
Narrative
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.
Additional 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.
Additional 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.
Description of Event or Problem
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.