PARAGON CRT100 CONTACT LENS

Additional Manufacturer Narrative

THE EVENT WAS REPORTED BY THE EYE CARE PRACTITIONER TO PARAGON. THE COMPLAINT WAS INVESTIGATED BY REVIEWING THE DEVICE HISTORY RECORD WHICH INDICATED THE LENS MET THE RELEASE REQUIREMENTS. THE LENS WAS NOT RETURNED FOR INSPECTION. AS INDICATED, THE DOCTOR SUGGESTED THERE WAS FOREIGN BODY THAT MAY HAVE BEEN TRAPPED UNDER THE LENS WHICH COULD HAVE BEEN THE CAUSED OF THE CENTRAL ULCER. THE PATIENT'S EYE IS COMPLETELY HEALED AND IS BACK TO WEARING PARAGON CRT100 LENS.

Description of Event or Problem

THE PATIENT DEVELOPED A SMALL CENTRAL ULCER ON HER RIGHT EYE AFTER WEARING THE LENS (B)(6) 2019. THE DOCTOR REPORTED THERE WERE SOME LINEAR TRACK MARKS THAT MAY INDICATE A FOREIGN BODY WAS TRAPPED UNDER THE LENS. THE PATIENT ALSO REPORTED THERE WAS PAIN. THE ULCER WAS TREATED WITH DROPS AND LENS WEAR WAS DISCONTINUED. WHEN THE PATIENT RETURNED ON (B)(6) 2019, THE ULCER WAS MOSTLY HEALED, NO LOSS OF VISION WAS REPORTED OR RECORDED. ON (B)(6) 2019, THE DOCTOR NOTED THE PATIENT'S EYE HAS COMPLETELY HEALED, THERE WERE NO EPITHELIAL DEFECTS AND NO LOSS OF VISION. THE PATIENT HAS RESUMED LENS WEAR AND IS DOING WELL IN THE LENSES.