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U.S. Department of Health and Human Services

Class 2 Device Recall Epic 5100) Refractor and RT 3100 Refractor

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  Class 2 Device Recall Epic 5100) Refractor and RT 3100 Refractor see related information
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
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
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
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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