UNKNOWN

Description of Event or Problem

ON (B)(6) 2015, AVEDRO RECEIVED A LETTER FROM THE DEPT OF HEALTH AND HUMAN SERVICES REGARDING A VOLUNTARY MEDWATCH (MW5042042) SUBMITTED BY A PATIENT WHO WAS ENROLLED IN AN UNIDENTIFIED CLINICAL STUDY (STUDY REFERENCE NUMBER AND STUDY INVESTIGATOR WERE NOT IDENTIFIED IN THE REPORT) FOR CORNEAL COLLAGEN CROSS-LINKING (CXL) ON OR ABOUT (B)(6) 2013. THE PATIENT REPORTED THAT SHE HAD SEVERE FLUCTUATING VISION DUE TO A RADIAL KERATOTOMY PROCEDURE IN THE LATE 1990'S. IN 2013, THE STUDY INVESTIGATOR CONDUCTED A THERMAL CONDUCTIVE KERATOPLASTY (TCK) ON THE LEFT EYE (48 SPOTS WELDED) ONE DAY BEFORE THE CXL PROCEDURE. AFTER THE TCK, THE PATIENT LOST ALL FUNCTIONAL VISION WITH SEVERE PAIN. THE NEXT MORNING, THE INVESTIGATOR PERFORMED THE CXL PROCEDURE ON THE PATIENT'S LEFT EYE. IMMEDIATELY AFTER THE CXL PROCEDURE, THE PATIENT'S VISION WAS EVEN MORE DISTORTED, WITH SEVERE DRY EYE AND EXTREME PAIN. IT IS UNCLEAR WHETHER OR NOT THE PATIENT RETURNED TO THE STUDY SITE A YEAR LATER FOR A FOLLOW-UP. THE PATIENT REPORTED THAT SHE IS UNABLE TO DRIVE AND HAS POOR QUALITY OF LIFE DUE TO PAIN AND VERY POOR VISION.

Additional Manufacturer Narrative

THERE ARE NO AVEDRO PRODUCTS OR IDENTIFIERS IN MW5042042. NEITHER OF THE TWO MEDICAL PRODUCTS INCLUDED IN THE REPORT: AN OPTHALMIC SPONGE AND BRANDED EQUIPMENT: "UV ULTRA LIGHT" ARE SOLD, DISTRIBUTED OR USED IN ANY WAY BY AVEDRO. AVEDRO'S CROSSLINKING TECHNOLOGY IS IN PRE-APPROVAL STATUS IN THE UNITED STATES. CLINICAL TRAILS WITH AVEDRO'S CROSS-LINKING TECHNOLOGY WERE ONGOING AROUND THE DATE OF THE EVENT. BASED ON THE PATIENT'S DESCRIPTION OF THE EVENT, AND HER MEDICAL HISTORY, IT DOES NOT APPEAR THE PATIENT WAS ENROLLED IN ANY OF AVEDRO'S CLINICAL TRAILS. ELIGIBILITY REQUIREMENTS OF THE CLINICAL STUDY WOULD HAVE PRECLUDED THIS PATIENT FROM ENROLLING IN THE AVEDRO STUDIES DUE TO THE PREVIOUS RADIAL KERATOTOMY (RK) AND THE TCK. IN ADDITION, RK (EXCLUSIONARY ON ITS OWN) RESULTS IN SCARRING TO THE EYE THAT WOULD HAVE BE NOTABLE TO MEDICAL STAFF DURING THE INITIAL BASELINE EXAM - AND CONSEQUENTLY RESULT IN SECONDARY EXCLUSION OF THE SUBJECT FROM PARTICIPATION IN ANY OF AVEDRO'S CLINICAL STUDIES. ADDITIONALLY, THE STUDY PROTOCOLS DO NOT ALLOW ANOTHER PROCEDURE, EXPERIMENTAL OR OTHERWISE, TO BE PERFORMED ON THE STUDY EYE WITHIN 30 DAYS OF THE STUDY ENROLLMENT. AVEDRO EVALUATED SERIOUS ADVERSE EVENTS REPORTED IN AVEDRO'S CLINICAL STUDIES AND THIS PATIENT'S INITIALS OR EVENT NARRATIVE DO NOT MATCH ANY OF OUR REPORTS. BASED UPON THE AVEDRO INVESTIGATION AND THE INFORMATION PROVIDED BY THE REPORTER, THE PRODUCTS INVOLVED IN THIS EVENT WERE NOT MANUFACTURED BY AVEDRO. A FOLLOW-UP REPORT TO THE FDA WILL BE PROVIDED SHOULD NEW, CONTRADICTORY INFORMATION BE MADE AVAILABLE.