LIPIFLOW THERMAL PULSATION SYSTEM CONSOLE
Received Jul 26, 2019 · Event occurred Jun 28, 2019
Report 3008169506-2019-00005 · MDR key 8833980
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Pain
- Red Eye(s)
- Unspecified Infection
- Pain
- Red Eye(s)
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 (B)(4) AND CAPA-010215.
Additional 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.
Description of Event or Problem
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.