Recall Z-1853-2014— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2014-06-09, terminated 2015-10-30. FDA's recall record names no specific 510(k) clearance for this event. Product: RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.. Reason: Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury..
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-09
- Terminated
- 2015-10-30
- Firm location
- Fremont, CA, United States
Product description
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.
Reason for recall
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.