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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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:
Related recalls
Same manufacturer · Nidek Inc.
See all →- LowNidek Specular Microscope Recalled for Electromagnetic Noise Exceeding Standards
FDA (Devices) · 2020-01-08
- ModerateNidek ARK-1s Auto Ref/Keratometer Recalled for Measurement Discrepancy
FDA (Devices) · 2018-04-18
- HighNidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming
FDA (Devices) · 2017-03-29
- ModerateNidek Specular Microscope CEM-530 Software Recall for Unapproved Feature
FDA (Devices) · 2016-09-07
- HighNidek Optical Biometer AL-Scan Recalled for Inaccurate Axial Length Measurements
FDA (Devices) · 2016-08-24
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighNidek RT-5100 and RT-3100 Refractors Recalled for Arm Malfunction
FDA (Devices) · 2016-03-30
- HighNidek RT-5100 and RT-3100 Refractors Recalled for Potential Injury
FDA (Devices) · 2014-07-02
- ModerateNidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label
FDA (Devices) · 2014-08-06
- LowNidek GYC-1000 Green Laser Photocoagulator Recalled for Missing Aperture Label
FDA (Devices) · 2014-08-20
- ModerateNidek ARK-1s Auto Ref/Keratometer Recalled for Measurement Discrepancy
FDA (Devices) · 2018-04-18
- ModerateNidek EC-5000 Excimer Laser System Recalled for Unapproved Manual Feature
FDA (Devices) · 2015-06-10