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.
This recall has been terminated (originally issued March 24, 2016).
- Company
- Nidek Inc
- Recall Initiated
- February 29, 2016
- Posted
- March 24, 2016
- Terminated
- September 24, 2018
- Recall Number
- Z-1245-2016
- Quantity
- 2703 separate serial numbers
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution
Lot / Code Info
serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
Root Cause
Component design/selection
Action Taken
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.
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