ON (B)(6) 2015, SYNERGEYES RECEIVED A COMPLAINT WHEREIN THE REASONS FOR RETURN WERE "CORNEAL ULCER" AND "DEFECTIVE". REPORT STATED, "TWO LENSES STUCK TOGETHER" AND ATTEMPTED TO DESCRIBE HOW THIS OCCURRED, "PATIENT HAD LENS IN EYE FOR TWO WEEKS AND UNAWARE - TOOK LENS OUT." ALSO INCLUDED WAS THAT THE PATIENT NOTICED A BUMP UNDER UPPER LID DUE TO IRRITATION FOR TWO DAYS. TREATMENT INDICATED WAS THERAPEUTIC VIGAMOX, WHICH HAD RESOLVED THE ISSUE WITH NO SECONDARY COMPLICATIONS BY THE DATE OF THE REPORT. ON (B)(6) 2015, SYNERGEYES CONTACTED ECP AND THE FOLLOWING INFORMATION WAS OBTAINED: ECP CONFIRMED ULCER OCCURRED. STATED THAT PATIENT WORE TWO LENSES IN THE AFFECTED EYE AT THE SAME TIME. THIS IS NOT A RECOMMENDED PROCEDURE. ALSO STATED PATIENT WAS UNAWARE FIRST LENS HAD BEEN IN EYE UPON INSERTION OF SECOND LENS. LENSES TORN UPON REMOVAL.
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Patient 1
OUR REVIEW OF THE DEVICE HISTORY RECORD OF THE REPORTED LENS DID NOT INDICATE ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO AN INJURY OF THIS NATURE WITHOUT THE PATIENT USING TWO SYNERGEYES LENSES IN ONE EYE, WHICH IS NOT A RECOMMENDED PROCEDURE. ALTHOUGH LENSES WERE RETURNED, THEY WERE NOT ACCOMPANIED BY ANY PAPERWORK. THE RELEVANT PAPERWORK WAS RETURNED AT A LATER DATE AND BY THE TIME THE PAPERWORK ARRIVED, THE LENSES HAD BEEN DISCARDED BY THE RETURNS DEPARTMENT. THERE WAS NO INDICATION ON ANY RECEIVED PACKAGING THAT THE LENSES WERE RELATED TO ANY INJURY.
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens