FORM FIT HYDROGEL CANALICULAR PLUG

Additional Manufacturer Narrative

REPORTED EVENT: PATIENT DEVELOPED CHRONIC CANALICULITIS IN THE LEFT EYE. PRODUCT REFERENCE: 6303. PRODUCT LOT NUMBER: LH0810A. PRODUCT INSERTED ON: (B)(6) 2011. DATE OF COMPLICATION: (B)(6) 2012. REPORTED TO OASIS MEDICAL, INC. ON (B)(6) 2013. DISCUSSION: ATTEMPTS MADE TO FLUSH THE PLUG FROM THE CANALICULUS WERE UNSUCCESSFUL. THE CANALICULUS WAS NOT CHECKED FOR PATENCY PRIOR TO INSERTION OF THE OASIS MEDICAL FORM FIT HYDROGEL PLUG. AFTER THE ATTEMPTED CANALICULAR FLUSH AND TOPICAL ANTIBIOTIC THERAPY WAS UNSUCCESSFUL THE PATIENT WAS REFERRED TO AN OCULOPLASTIC SURGEON. THE SURGEON SURGICALLY REMOVED THE GRANULOMA AND WHAT APPEARED TO BE A RESIDUAL PLUG. CULTURE OF THE REMOVED DEVICE SHOWED ACTINOMYCES ISRAELII. THE ISSUE WAS RESOLVED FOR THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN AS TO THE DIRECT CAUSE OF THE REPORTED ADVERSE EVENT.

Description of Event or Problem

REPORTED OBSERVATION: PATIENT DEVELOPED CHRONIC CANALICULITIS AFTER INSERTION OF AN OASIS MEDICAL FORM FIT HYDROGEL CANALICULAR PLUG IN THE LEFT EYE.