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.
This recall has been terminated (originally issued June 23, 2014).
- Company
- Nidek Inc
- Recall Initiated
- June 9, 2014
- Posted
- June 23, 2014
- Terminated
- October 30, 2015
- Recall Number
- Z-1853-2014
- Quantity
- ~4,285 units RT-5100; 167 units of RT-3100
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Distribution
US distribution only.
Lot / Code Info
RT-5100 and RT-3100, various serial numbers.
Root Cause
Use error
Action Taken
Recall/Field Correction letters were sent to doctors on June 9, 2014 with a preventive maintenance instruction to be performed on the device by user. Also included are the necessary tools to perform actions. Customers are to complete and return the Recall Response Card. Questions are to be directed to Customer Service. Contact Information: Customer Service: 1-800-891-1772 E-mail: RT-5100 update@noritsu.com
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