Recall Z-1245-2016
Nidek Inc · initiated February 29, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
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: 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.
Details
- Recall number
- Z-1245-2016
- Initiated
- February 29, 2016
- Posted by FDA
- March 24, 2016
- Terminated
- September 24, 2018
- Product code
- HKN – Refractor, Manual, Non-Powered, Including Phoropter
- Quantity
- 2703 separate serial numbers
- Distribution
- US Nationwide Distribution
- Recalling firm
- Nidek Inc, Fremont, CA