FDAFDA · Food and drugs·Recall number Z-0655-2019
RT-5100 Refractor, a component of the Epic-5100 System.
Published December 26, 2018 · Recall initiated: June 14, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The lens bonding was incomplete on the refractor.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Nidek Inc.
- Distributor
- Distribution was made to FL.
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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