Reported Feb 28, 2018 · Terminated
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label…
Oculus Optikgeraete GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Oculus Optikgeraete GMBH · Munchholzhauser Str. 29 · Wetzlar, N/A · N/A
Is this the product you have?
- OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
- Lot codes and dates
- Serial numbers
83 of 83 codes
70100 0021 619070100 0301 517070100 0311 615070100 0331 713070100 0401 510170100 0421 610170100 0641 717070100 0831 715070100 1021 619070100 1101 517070100 1541 717070100 1631 714070100 1731 714070100 1831 715070100 1901 613070100 2211 615070100 2221 619070100 2231 713070100 2241 716070100 2511 617070100 2641 717070100 2731 714070100 2801 613070100 2821 711070100 2931 715070100 3221 619070100 3701 611070100 3731 714070100 3931 715070100 4041 716070100 4211 615070100 4231 713070100 4401 512170100 4511 617070100 4711 617070100 4831 715070100 4931 715070100 5311 616070100 5531 714070100 5611 617070100 5621 611170100 5831 715070100 5931 715070100 6101 517070100 6221 610170100 6231 713070100 6331 713070100 6401 512170100 6421 610170100 6631 714070100 6801 613070100 6811 619070100 6821 711070100 7041 716070100 7221 610170100 7401 512170100 7511 617070100 7531 714070100 7631 714070100 7731 7150
- Serial numbers
- Amount recalled
- 83 devices
Where it was sold
Why it was recalled
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
This product could cause temporary or reversible health problems — stop using it.
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