🔍 RecallPedia

Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Class I - Dangerous
🏥 Medical Devices Recalled: July 8, 2022 Oculus Optikgeraete GMBH Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Software version: 1.26r26 and 1.26r27 Model Number: 70100 UDI-DI Code: 04049584012333 Serial Numbers: 70100 0301 5170 70100 0332 1280 70100 0351 7190 70100 0421 6101 70100 0461 7121 70100 0561 8130 70100 0641 7170 70100 0981 9120 70100 1032 1270 70100 1171 8180 70100 1291 9130 70100 1491 9140 70100 1551 7190 70100 1631 7140 70100 1632 2210 70100 1751 7190 70100 1802 0250 70100 1881 9120 70100 2181 8101 70100 2651 7190 70100 2731 7140 70100 2821 7110 70100 2912 1220 70100 3122 1240 70100 3141 7160 70100 3221 6190 70100 3222 1240 70100 3541 7160 70100 3561 8130 70100 3691 9160 70100 3701 6110 70100 3722 1270 70100 3881 9120 70100 3931 7150 70100 4012 0270 70100 4032 1270 70100 4502 0230 70100 4511 6170 70100 4922 1270 70100 4961 8170 70100 5032 1270 70100 5071 8180 70100 5141 7160 70100 5232 1280 70100 5311 6160 70100 5332 1290 70100 5441 7160 70100 5461 7121 70100 5621 6111 70100 5651 7190 70100 5661 8130 70100 5671 8101 70100 5981 9120 70100 6022 1220 70100 6032 1270 70100 6171 8180 70100 6332 1290 70100 6421 6101 70100 6451 7190 70100 6631 7140 70100 6651 7190 70100 6751 7111 70100 6821 7110 70100 7511 6170 70100 7631 7140 70100 7781 9120 70100 7831 7150 70100 7861 8170 70100 8021 6190 70100 8121 6190 70100 8212 0290 70100 8332 1290 70100 8511 6170 70100 8512 0211 70100 8611 6170 70100 8731 7150 70100 8791 9170 70100 8822 1270 70100 8891 9170 70100 9081 8101 70100 9132 1280 70100 9171 8180 70100 9221 6101 70100 9231 7130 70100 9332 1290 70100 9361 7121 70100 9471 8101 70100 9822 1270 70100 9881 9120 70100 9911 6190 70100 9912 1220 70100 9931 7150
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Product Codes/Lot Numbers:

Software version: 1.26r26 and 1.26r27 Model Number: 70100 UDI-DI Code: 04049584012333 Serial Numbers: 70100 0301 5170 70100 0332 1280 70100 0351 7190 70100 0421 6101 70100 0461 7121 70100 0561 8130 70100 0641 7170 70100 0981 9120 70100 1032 1270 70100 1171 8180 70100 1291 9130 70100 1491 9140 70100 1551 7190 70100 1631 7140 70100 1632 2210 70100 1751 7190 70100 1802 0250 70100 1881 9120 70100 2181 8101 70100 2651 7190 70100 2731 7140 70100 2821 7110 70100 2912 1220 70100 3122 1240 70100 3141 7160 70100 3221 6190 70100 3222 1240 70100 3541 7160 70100 3561 8130 70100 3691 9160 70100 3701 6110 70100 3722 1270 70100 3881 9120 70100 3931 7150 70100 4012 0270 70100 4032 1270 70100 4502 0230 70100 4511 6170 70100 4922 1270 70100 4961 8170 70100 5032 1270 70100 5071 8180 70100 5141 7160 70100 5232 1280 70100 5311 6160 70100 5332 1290 70100 5441 7160 70100 5461 7121 70100 5621 6111 70100 5651 7190 70100 5661 8130 70100 5671 8101 70100 5981 9120 70100 6022 1220 70100 6032 1270 70100 6171 8180 70100 6332 1290 70100 6421 6101 70100 6451 7190 70100 6631 7140 70100 6651 7190 70100 6751 7111 70100 6821 7110 70100 7511 6170 70100 7631 7140 70100 7781 9120 70100 7831 7150 70100 7861 8170 70100 8021 6190 70100 8121 6190 70100 8212 0290 70100 8332 1290 70100 8511 6170 70100 8512 0211 70100 8611 6170 70100 8731 7150 70100 8791 9170 70100 8822 1270 70100 8891 9170 70100 9081 8101 70100 9132 1280 70100 9171 8180 70100 9221 6101 70100 9231 7130 70100 9332 1290 70100 9361 7121 70100 9471 8101 70100 9822 1270 70100 9881 9120 70100 9911 6190 70100 9912 1220 70100 9931 7150

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1673-2022

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