ILUX SYSTEM 1.0 DEVICE
Received Oct 27, 2020 · Event occurred Nov 13, 2018
Report 3014322342-2020-00001 · MDR key 10744229
Device
Generic name
Eyelid Thermal Pulsation System
Manufacturer
Tear Film Innovations IncModel number
1.0Catalog number
2020
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
85 YR
- Corneal Ulcer
- Pain
- Loss of Vision
- Corneal Ulcer
- Pain
- Loss of Vision
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PATIENT DEVELOPED CORNEAL PERFORATION IN THE RIGHT EYE.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE SERIAL NUMBER (S/N) WAS NOT PROVIDED AND COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THEREFORE, MANUFACTURING INFORMATION COULD NOT BE OBTAINED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem
AN ATTORNEY REPORTED THAT A PATIENT DEVELOPED A HOLE IN THE CORNEA (EYE UNKNOWN), EXPERIENCED PAIN, AND A LOSS OF VISION IN BOTH EYES FOLLOWING TREATMENT FOR DRY EYES. SUBSEQUENTLY THE PATIENT UNDERWENT A CORNEAL REPLACEMENT SURGERY, IN THE RIGHT EYE. IT WAS ALSO NOTED THAT THE PATIENT WAS DIAGNOSED WITH CORNEAL ULCER IN BOTH EYES AND CORNEAL REJECTION SOME MONTHS LATER. THE PATIENT UNDERWENT ADDITIONAL SURGERIES.