HUBBLE
Received Mar 30, 2026 · Event occurred Jan 12, 2026
Report 9617499-2026-00001 · MDR key 24710554
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
39 YR · Male
- Inflammation
- Keratitis
- Blurred Vision
- Eye Pain
- Eye Irritation
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER IS UNKNOWN AND THE PRODUCTS ARE NOT MADE AVAILABLE FOR EVALUATION AT THIS TIME. THE INFORMATION ABOUT PATIENT AND INITIAL REPORTER AS WELL AS OTHER INFORMATION REQUIRED TO SUBMIT WAS NOT PROVIDED. NO EVALUATION COULD BE PERFORMED. IF THE ADDITIONAL INFORMATION IS RECEIVED, THE FOLLOW-UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF THE RECEIPT. SUBSEQUENT ACTIONS REGARDING THE FOLLOW-UP REPORT WILL BE TAKEN AND SUBMITTED IN ACCORDANCE WITH 21 CFR 803.10 AND 803.56.
Description of Event or Problem
THE FOLLOWING INFORMATION WAS OBTAINED THROUGH MEDWATCH REPORT. REPORT NUMBER: MW5183254. THE EVENT DESCRIPTION WAS: "PATIENT'S EYE HAD AN ADVERSE REACTION TO WEARING CONTACTS THAT WERE NOT PRESCRIBED OR FIT TO HIS EYE. THIS CONTACT WAS GIVEN TO PATIENT WITHOUT A VALID RX THROUGH AN ONLINE SOURCE (B)(6). THE CONTACT FIT HIS EYE TOO TIGHTLY AND LED TO PAIN, REDNESS, AND INFLAMMATION ON HIS CORNEA WHICH ALSO CAUSED BLURRY VISION. THIS COULD HAVE RESULTED IN AN ULCER AND EVEN BLINDNESS IF NOT TREATED."