NIDEK HAD ALREADY REPORTED TO FDA SIMILAR ADVERSE EVENT AND REMEDIAL ACTION HAD TAKEN IN 2014 (Z-1853-2014). NIDEK ALSO HAS BEGUN ADDITIONAL FIELD CORRECTION (Z-1245-2016) ON 3/24/2016 SINCE NIDEK RECEIVED SIMILAR CUSTOMER COMPLAINTS. BASED ON OUR DATABASE, NIDEK WAS ABLE TO CONFIRM THIS RT-5100 (SERIAL NUMBER: (B)(4)) IS WITHIN THE SCOPE OF THE ONGOING RECALL (Z-1245-2016). THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. HOWEVER, NIDEK HIRED THIRD PARTY ((B)(4)) VISITED THE CUSTOMER SITE FOR ON-SITE EVALUATION AND PERFORMED THE CORRECTION AS PER THE RECALL. NIDEK CONFIRMED THAT THE INJURY WAS MINOR AND DID NOT NEED ANY SURGICAL OR MEDICAL INTERVENTION. NIDEK CONSIDERS IT A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
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Patient 1
NIDEK RECEIVED A COMPLAINT FROM A DISTRIBUTOR ON 04/27/2016. NIDEK HIRED THIRD PARTY, (B)(4) CALLED THIS CUSTOMER ON 04/26/2016 TO SCHEDULE INSTALLATION OF THE NIDEK NEAR POINT ARM UPGRADE TO PERFORM FIELD CORRECTION (Z-1245-2016). DURING THE CONVERSATION, THE OFFICE MANAGER IMMEDIATELY REPORTED THAT THERE WAS AN INCIDENT EARLIER TODAY WHERE THE NEAR POINT ROD ACTUALLY FELL ON THE DOCTOR STRIKING HIM FIRST IN THE FOREHEAD, AND THEN ON THE BRIDGE OF HIS NOSE CAUSING SOME NOTICEABLE MARKS WHERE IT STRUCK HIM. THE FORCE CAUSED A SMALL CUT ON HIS FOREHEAD AND BRIDGE OF THE NOSE. HE DID NOT REQUIRE MEDICAL ATTENTION, BUT THE SITE IS TENDER TO THE TOUCH.