FDAFDA · Food and drugs·Recall number Z-1853-2014
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.
Published July 2, 2014 · Recall initiated: June 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nidek Inc
- Distributor
- US distribution only.
- Lot
- RT-5100 and RT-3100, various serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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