NIDEK IN REC'D MAUDE EVENT REPORT (B)(4) 2014 THROUGH U.S DISTRIBUTOR, (B)(4). PHYSICIAN WAS DOING AN EYE EXAM. WHEN MOVING THE PHOROPTER, THE NEAR POINT ROD FELL DOWN AND HIT THE BRIDGE OF HER NOSE AND SHE OBTAINED A LACERATION. SINCE WE COULD NOT OBTAIN ADD'L INFO FROM OUR DISTRIBUTOR OR CUSTOMERS, THERE IS NO INFO INDICATING THAT THERE WAS A SERIOUS INJURY. HOWEVER, SINCE WE WOULD CONSIDER ANY INJURY TO THE FACE THAT CAN CAUSE SCARRING A SERIOUS INJURY AND IT IS REPORTABLE, WE DETERMINED TO SUBMIT THIS MDR.
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NIDEK CO., LTD.(B)(4) PERFORMED RISK ASSESSMENT TO DETERMINE WHETHER THE EVENT IS MDR REPORTABLE. WE CONCLUDED IT WOULD NOT BE A SERIOUS INJURY BASED ON THE RISK ASSESSMENT ON (B)(6) (27 CALENDAR DAYS). NIDEK INC. WAS UNDER FDA INSPECTION FROM (B)(4). NIDEK INC. WAS PREPARING A CORRECTIVE REPORT TO FDA AND HAD AN OPPORTUNITY TO DISCUSS ON OUR CORRECTION STRATEGY WITH (B)(4). DURING A TELECONFERENCE (B)(6) THAT A COMPLAINT RELATING LACERATION OF THE NOSE WAS A SERIOUS INJURY AS FOLLOWS "I DON'T THINK THE FIRMS' ANALYSIS OR STRATEGY IS APPROPRIATE. I WOULD CONSIDER ANY INJURY TO THE FACE THAT CAN CAUSE SCARRING A SERIOUS INJURY AND IT IS REPORTABLE." NIDEK INC. AND NIDEK CO., LTD. DETERMINED TO SUBMIT EACH MDR TO FDA BASED ON THE ADVISE FROM (B)(4) ON APRIL 7TH. WE SINCERELY APOLOGIZE WE DID NOT SUBMIT THIS MDR WITHIN 30 CALENDAR DAYS. ON THE OTHER HAND, OUR CORRECTION STRATEGY IN THE DRAFT OF CUSTOMER NOTIFICATION LETTER WAS ACCEPTED BY ALL FDA ATTENDEES IN THE TELECONFERENCE ON (B)(4). OUR STRATEGY IS TO PROVIDE PREVENTIVE MAINTENANCE KIT INCLUDING HEX WRENCH, GLUE AND INSTRUCTIONS FOR USE TO ALL CUSTOMERS WHO PURCHASED RT-5100 OR RT-3100. NIDEK INC. HAS ALREADY SUBMITTED RECALL REPORT (2936921-4/17/2014-001-C) DATED 4/17/2014 TO (B)(4).