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.
FDA Recall Z-1853-2014 · Posted 2014-06-23
Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeHKN
Date Initiated2014-06-09
Date Terminated2015-10-30
Product Quantity~4,285 units RT-5100; 167 units of RT-3100
Reason for Recall
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Firm Action
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 [email protected]
Root Cause
Use error
Distribution Pattern
US distribution only.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.