LIPIFLOW ACTIVATOR II
Received Oct 2, 2019 · Event occurred Aug 29, 2019
Report 3008169506-2019-00007 · MDR key 9146259
Device
Generic name
Lipiflow
Manufacturer
Johnson & Johnson Surgical Vision, Inc.Model number
LFD-2000Catalog number
220150
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4). A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING THE ACTIVATOR LOT# 1913320013. PRODUCT MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A FEW DAYS AFTER LIPIFLOW TREATMENT THE PATIENT DEVELOPED A CHALAZION IN THE RIGHT EYE. THE EYE WAS RED AND SORE. SYMPTOMS STARTED TO DEVELOP IN THE LEFT EYE AS WELL AFTERWARD. THERE WERE NO ISSUES DURING THE TREATMENT AND SHE HAD NONE VISIBLE ON THE DAY OF TREATMENT. NO TREATMENT AT THE TIME WAS GIVEN. DURING FOLLOW UP IT WAS REPORTED THAT PATIENT STARTED USING AN ANTIBIOTIC DROP. IT WAS ALSO REPORTED THAT THE PATIENT HAD STYES AND NOT CHALAZIONS. THIS REPORT IS FOR THE LEFT EYE. A REPORT FOR THE RIGHT EYE IS BEING SUBMITTED FOR SEPARATELY.