Recall Z-1245-2016— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2016-02-29, terminated 2018-09-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-29
- Terminated
- 2018-09-24
- Firm location
- Fremont, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.