Z-1245-2016 Class II Terminated
FDA device recall Z-1245-2016 was initiated by Nidek Inc on February 29, 2016 and is designated Class II. Reason for recall: There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient. The recall status is terminated (terminated September 24, 2018). Affected quantity: 2703 separate serial numbers.
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2016
- Initiation Date
- February 29, 2016
- Termination Date
- September 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2703 separate serial numbers
Product Description
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
Reason for Recall
There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.
Distribution Pattern
US Nationwide Distribution
Code Information
serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.