Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software version: 1.26r26 and 1.26r27 Model Number: 70020 UDI-DI Code: 04049584025357 Serial Numbers: 70020 0111 0201 70020 0211 0201 70020 0311 0211 70020 0711 1230 70020 1211 0201 70020 1321 1211 70020 2411 0211 70020 2911 1250 70020 3511 0211 70020 3801 0230 70020 4701 0210 70020 4811 1250 70020 5411 0211 70020 5701 0210 70020 6611 1230 70020 6621 1211 70020 7011 0201 70020 7511 1230 70020 8021 1290 70020 8701 0210 70020 9011 0201
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Oculus Optikgeraete GMBH
- Reason for Recall:
- Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Product Codes/Lot Numbers:
Software version: 1.26r26 and 1.26r27 Model Number: 70020 UDI-DI Code: 04049584025357 Serial Numbers: 70020 0111 0201 70020 0211 0201 70020 0311 0211 70020 0711 1230 70020 1211 0201 70020 1321 1211 70020 2411 0211 70020 2911 1250 70020 3511 0211 70020 3801 0230 70020 4701 0210 70020 4811 1250 70020 5411 0211 70020 5701 0210 70020 6611 1230 70020 6621 1211 70020 7011 0201 70020 7511 1230 70020 8021 1290 70020 8701 0210 70020 9011 0201
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1672-2022
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