D
Patient 1
ON 2014 SYNERGEYES RECEIVED A COMPLAINT WHEREIN THE PATIENT EXPERIENCED A "FOREIGN BODY" SENSATION WHILE WEARING THE CONTACT LENS. SYNERGEYES CONTACTED (B)(6) OD, THE ATTENDING (B)(6) AT THE UNIVERSITY EYE ASSOCIATES ON (B)(6) 2014 DETERMINED THE FOLLOWING ADDITIONAL INFORMATION. ON APPROXIMATELY (B)(6) 2014, THE PATIENT CONTACTED THE (B)(6) AND STATED THAT THE CONTACT LENS WAS UNCOMFORTABLE. THE PATIENT WAS INSTRUCTED BY THE ECP TO DISCONTINUE THE USE OF THE LENS. THE PATIENT WAS NOT SEEN BY THE ECP. ON APPROXIMATELY (B)(6) 2014, THE PATIENT AGAIN REPORTED DISCOMFORT WHILE WEARING THE CONTACT LENS. THE ECP AGAIN INSTRUCTED THE PATIENT TO DISCONTINUE THE USE OF THE LENS. THE PATIENT WAS NOT SEEN BY THE ECP. THE PATIENT WAS EXAMINED BY THE ECP ON (B)(6) 2014 WHEREIN THE PATIENT WAS FOUND TO HAVE A SMALL SUPERFICIAL PUNCTATE KERATOPATHY (SPK) AND MINOR STAINING IN TH E LEFT EYE. THERE WAS NO ABRASION OR OTHER CORNEAL DEFECT DETECTED DURING THE EXAMINATION. THE LENS WAS INSPECTED BY THE ECP WHO DETERMINED THAT THERE WAS A "FRACTURE IN THE LENS MATERIAL." THE ECP ADVISED THE PATIENT TO DISCONTINUE THE USE OF THE CONTACT LENS AND UNDERGO TREATMENT. PATIENT TREATMENT CONSISTED OF DISCONTINUING THE USE OF THE LENS AND WEARING AN "AIR-OPTIX DAY AND NIGHT" BANDAGE OVER THE LEFT EYE FOR 24 HOURS. THE PATIENT HAS A PRE-EXISTING CONDITION (KERATOCONUS) WHICH MAY HAVE CONTRIBUTED TO THE EVENT. ALSO THE PATIENT WORE THE FRACTURED CONTACT LENS AFTER BEING ADVISED TO DISCONTINUE THE USE OF THE LENS. ON (B)(6) 2014, THE PATIENT WAS SEEN BY THE ECP. THE PATIENT WAS DOING "FINE" AND THE SPK HEALED.