Nidek RT-5100 Refractor Recalled for Incomplete Lens Bonding
Nidek Inc. is recalling 85 RT-5100 Refractors distributed in Florida because the lens bonding was incomplete.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and no injuries or illnesses are reported in the source text.
Plain-English summary
Nidek Inc. is recalling 85 units of the RT-5100 Refractor, a component of the Epic-5100 System. The recall was initiated because the lens bonding on the refractor was incomplete.
The affected instruments were distributed to Florida. The specific serial numbers involved range from 921042 to 921103 and from 150028 to 150052, with specific exclusions noted in the official record.
Consumers and healthcare providers should stop using the affected refractors and contact Nidek Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- RT-5100 Refractor, a component of the Epic-5100 System.
- Manufacturer
- Nidek Inc.
- Hazard
- Affected units
- 85
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers 921042
- 921043
- 921044
- 921045
- 921046
- 921047
- 921048
- 921049
- 921050
- 921051
- 921052
- 921053
- 921054
- 921055
- 921056
- 921057
- 921058
- 921059
- 921060
- 921061
Distribution
Distributed in 1 state:
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