DRAPE OPHTHALMIC INCISE W/POUCH

Additional Manufacturer Narrative

CARDINAL HEALTH IS PROACTIVELY FILING THIS COMPLAINT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO QUALITY ISSUES WERE REPORTED. AN EVALUATION OF THE RETURNED REPRESENTATIVE SAMPLE WAS COMPLETED FOR MATERIAL, FOLDS, POUCH AND FINISHED DIMENSIONS. NO DEFECTS WERE FOUND. BASED ON THE EVALUATION OF THE SAMPLE AND THE DHR, THE ISSUE OF AGGRESSIVE ADHESIVE WAS NOT CONFIRMED. IN ADDITION, ALL FINISHED GOODS ARE MADE FROM QUALIFIED MATERIALS THAT ARE TESTED BEFORE USE. FINAL FINISHED PRODUCT MUST MEET PRODUCT SPECIFICATION AND PROCESS REQUIREMENTS BEFORE FINAL RELEASE TO SALABLE INVENTORY. A ROOT CAUSE WAS NOT DETERMINED AND NO CORRECTIVE ACTION WAS TAKEN. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

Description of Event or Problem

RECEIVED COMPLAINT THAT STATED THE ADHESIVE ON THE DRAPE WAS TOO STRONG, AND PEELED THE SKIN AND RIPPED EYE LASHES OFF WHEN REMOVING. THE COMPLAINT WAS ORIGINALLY RECEIVED IN MAY, AND MULTIPLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION FROM THE CUSTOMER, HOWEVER THE END USER DID NOT RESPOND. ON (B)(6) THE CUSTOMER REPORTED THAT THE END USER HAD CONTACTED THEM WITH INFORMATION THAT ANTIBIOTIC OINTMENT AND STEROIDS WERE USED FOR PEELED SKIN; AND THAT SKIN AND LASHES ARE OK NOW. THE CUSTOMER REPORTED THAT THEY DOUBTED THERE WOULD BE ANY FURTHER SPECIFIC INFORMATION FROM THE END USER.