| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RT-5100 | REFRACTOR | NIDEK CO., LTD. | HKN | RT-5100 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-12-01 | 0 |
Patient 1
NIDEK RECEIVED A COMPLAINT FROM THE CUSTOMER ON (B)(6) 2014. CUSTOMER REPORTED THAT DURING THE USE OF RT-5100 SN (B)(4), THE NEAR POINT CHART ARM FELL DOWN. THE NEAR POINT CHART ARM HIT THE DOCTOR ON THE HEAD. DOCTOR COMPLAINED OF BLOODY HEAD DUE TO THE ARM.
Patient 1
THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. THE DEVICE HAS NOT BEEN EVALUATED YET. SERVICE ENGINEER COULD CONDUCT AN ON-SITE EVALUATION. CUSTOMER REPORTED THAT THE EVENT OCCURRED LONG TIME BACK (DATE NOT SPECIFIED BY CUSTOMER) BEFORE THE PM WAS DONE. CUSTOMER THEN PERFORMED THE PREVENTATIVE MAINTENANCE (PM) ACCORDING TO THE RECALL PROCEDURE. THE PROBLEM HAS BEEN RESOLVED AFTER THE PM. NIDEK CONTACTED THE CUSTOMER TO VERIFY THE COMPLAINT ABOUT THE INJURY AND CONFIRMED THAT THE INJURY WAS MINOR, IT WAS A SMALL DENT/LACERATION. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED FOR THE INJURY. NIDEK ALSO CONFIRMED THAT THE EVENT HAD OCCURRED BEFORE THE PM AND THE ISSUE HAS BEEN RESOLVED AFTER THE PM. IF ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED AT A LATER DATE AFTER THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. NIDEK INC. CONSIDERS IT A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL CAUSE OR CONTRIBUTED TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THE FACILITY HAS TWO UNITS SN (B)(4) AND SN (B)(4) AND THE COMPLAINT COULD NOT BE CONFIRMED WITH WHICH DEVICE THE EVENT HAPPENED. SO NIDEK WILL SUBMIT TWO SEPARATE MDR FOR BOTH THE SN. PLEASE REFER TO MDR 3002807715-2014-00040.