LIPIFLOW ACTIVATOR II
Received Dec 28, 2018
Report 3008169506-2018-00104 · MDR key 8203371
Device
Generic name
Lipiflow
Manufacturer
Johnson & Johnson Surgical Vision, IncModel number
LFD-2000Catalog number
210000
Lot number
UNKNOWN/NOT PROVIDED
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Bruise/Contusion
- Swelling
- Bruise/Contusion
- Swelling
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
DATE OF EVENT UNKNOWN. LOT#: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. 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
ACCOUNT REPORTED A PATIENT HAD BRUISING AND SWELLING 8 DAYS AFTER A LIPIFLOW TREATMENT.