RT-5100 recall
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms…
Why was RT-5100 recalled?
There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
- Product
- RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms…
- Recalling firm
- Nidek Inc
- Quantity
- 2703 separate serial numbers
- Distribution
- US Nationwide Distribution
- Recall date
- March 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)