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U.S. Department of Health and Human Services

Class 3 Device Recall RT5100 Refractor

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 Class 3 Device Recall RT5100 Refractorsee related information
Date Initiated by FirmJune 14, 2018
Create DateDecember 21, 2018
Recall Status1 Terminated 3 on June 03, 2020
Recall NumberZ-0655-2019
Recall Event ID 81529
Product Classification Refractor, manual, non-powered, including phoropter - Product Code HKN
ProductRT-5100 Refractor, a component of the Epic-5100 System.
Code Information Serial numbers 921042, 921043, 921044, 921045, 921046, 921047, 921048, 921049, 921050, 921051, 921052, 921053, 921054, 921055, 921056, 921057, 921058, 921059, 921060, 921061, 921062, 921063, 921064, 921065, 921066, 921067, 921068, 921069, 921070, 921071, 921072, 921073, 921074, 921075, 921076, 921077, 921078, 921079, 921080, 921081, 921084, 921085, 921086, 921087, 921088, 921089, 921090, 921091, 921092, 921093, 921094, 921095, 921096, 921097, 921098, 921099, 921100, 921101, 921102, 921103, 150028, 150029, 150030, 150031, 150032, 150033, 150034, 150035, 150036, 150037, 150038, 150039, 150040, 150041, 150042, 150043, 150044, 150045, 150046, 150047, 150048, 150049, 150050, 150051, and 150052
Recalling Firm/
Manufacturer		 Nidek Inc.
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information ContactMr. Toshio Murata
800-223-9044
Manufacturer Reason
for Recall		The lens bonding was incomplete on the refractor.
FDA Determined
Cause 2		Employee error
ActionThe recalling firm called the sole distributor on 6/14/2018 to determine the quantity of instruments still in their control. During the phone call, the distributor was also notified of the invoice numbers that show the serial numbers involved, was asked to segregate the affected product, and a schedule was discussed for the recalling firm's technicians to visit the distributor for correction of the product.
Quantity in Commerce85 instruments
DistributionDistribution was made to FL.
Total Product Life CycleTPLC 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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