RT-5100 recall
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.
Why was RT-5100 recalled?
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
RT-5100 and RT-3100, various serial numbers.
- 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.
- Recalling firm
- Nidek Inc
- Quantity
- ~4,285 units RT-5100; 167 units of RT-3100
- Distribution
- US distribution only.
- Recall date
- July 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)