Nidek Inc.: Medical Device Recall in 2018 - (Recall #: Z-0655-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

RT-5100 Refractor, a component of the Epic-5100 System.

Product Classification:

Class III

Date Initiated: June 14, 2018

Date Posted: December 26, 2018

Recall Number: Z-0655-2019

Event ID: 81529

Reason for Recall:

The lens bonding was incomplete on the refractor.

Status: Terminated

Product Quantity: 85 instruments

Code Information:

Serial numbers 921042, 921043, 921044, 921045, 921046, 921047, 921048, 921049, 921050, 921051, 921052, 921053, 921054, 921055, 921056, 921057, 921058, 921059, 921060, 921061, 921062, 921063, 921064, 921065, 921066, 921067, 921068, 921069, 921070, 921071, 921072, 921073, 921074, 921075, 921076, 921077, 921078, 921079, 921080, 921081, 921084, 921085, 921086, 921087, 921088, 921089, 921090, 921091, 921092, 921093, 921094, 921095, 921096, 921097, 921098, 921099, 921100, 921101, 921102, 921103, 150028, 150029, 150030, 150031, 150032, 150033, 150034, 150035, 150036, 150037, 150038, 150039, 150040, 150041, 150042, 150043, 150044, 150045, 150046, 150047, 150048, 150049, 150050, 150051, and 150052

Distribution Pattern:

Distribution was made to FL.

Voluntary or Mandated:

Voluntary: Firm initiated