Device 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.
Z-1245-2016
Product summary
- Firm
- Nidek Inc
- Event
- Event 73316
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2703 separate serial numbers
- Official record key
device-enforcement:Z-1245-2016
Official wording
Reason: 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.
Code information: serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.