LIPIFLOW THERMAL PULSATION SYSTEM CONSOLE
Received Jul 2, 2019 · Event occurred May 27, 2019
Report 3008169506-2019-00004 · MDR key 8756398
Device
Generic name
Lipiflow
Manufacturer
Johnson & Johnson Surgical Vision, Inc.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
CORRECTION: MANUFACTURING DATE: THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS DECEMBER 2013.
Additional Manufacturer Narrative
(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. PHYSICIAN PRESCRIBED STEROID DRUG, ARTIFICIAL EYEDROP TO PATIENT FOR RELIEF THE SYMPTOM. IT WAS REPORTED THAT PATIENT RECOVERED.