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Recall Observatory FDA recall evidence

Device product

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

Z-0655-2019

June 14, 2018

Class III

Product summary

Firm
Nidek Inc.
Event
Event 81529
Status
Terminated
Classification
Class III
Quantity
85 instruments
Official record key
device-enforcement:Z-0655-2019

Official wording

Reason: The lens bonding was incomplete on the refractor.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The lens bonding was incomplete on the refractor.