BOSTONSIGHT PROSE

Description of Event or Problem

PATIENT STATES THAT UPON REMOVAL OF THE DEVICE HER EYE SWELLED AND BECAME RED. PT. REPORTED PAIN AND BLURRED VISION.

Additional Manufacturer Narrative

THE DESIGN PROFILE FOR THE LENS WAS REVIEWED. THE THICKNESS WAS ADEQUATE AND PER SPECIFICATION, AND THE DESIGNS WERE STABLE. THE FITCONNECT WORK ORDER AND PROCESS CONTROL LOG WERE REVIEWED - THE THICKNESS WAS ADEQUATE AND PER SPECIFICATION, AND THE DESIGN WAS STABLE. THE DEVICE WAS MANUFACTURED CORRECTLY AND WITHIN ALL SPECIFIED TOLERANCES. NO OTHER COMPLAINTS HAVE BEEN LOGGED FOR THIS SPECIFIC B&L MATERIAL LOT NUMBER A REVIEW OF THE NONCONFORMING MATERIALS REPORTS SHOWS NO NCR'S LOGGED FOR THIS SPECIFIC MATERIAL LOT NUMBER. THE B&L CERTIFICATE OF ANALYSIS AND INCOMING INSPECTION REPORTS FOR THE LOT WERE REVIEWED - NO ISSUES WITH THE MATERIAL.