Date Initiated by Firm | February 29, 2016 |
Date Posted | March 24, 2016 |
Recall Status1 |
Terminated 3 on September 24, 2018 |
Recall Number | Z-1245-2016 |
Recall Event ID |
73316 |
Product Classification |
Refractor, manual, non-powered, including phoropter - Product Code HKN
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Product | RT-5100 (Epic 5100) Refractor and RT 3100 Refractor:
Product Usage:
Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions. |
Code Information |
serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100. |
Recalling Firm/ Manufacturer |
Nidek Inc 47651 Westinghouse Dr Fremont CA 94539-7474
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For Additional Information Contact | Preeti Ghandi 510-353-7785 |
Manufacturer Reason for Recall | There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient. |
FDA Determined Cause 2 | Component design/selection |
Action | Nidek sent a Recall letters dated February 29, 2016 to all affected site. The letter identified the affected product, problem and actions to be taken. Nidek Customer Service will be replacing the affected product with new parts to address this recall. For questions call Customer Service at 1-800-722-0219. |
Quantity in Commerce | 2703 separate serial numbers |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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