Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Reported: September 7, 2022 Initiated: July 8, 2022 #Z-1673-2022
Product Description
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
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
Details
- Recalling Firm
- Oculus Optikgeraete GMBH
- Units Affected
- 92 systems with affected software
- Distribution
- U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY O.U.S.: N/A
- Location
- Wetzlar
Frequently Asked Questions
What product was recalled? ▼
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.. Recalled by Oculus Optikgeraete GMBH. Units affected: 92 systems with affected software.
Why was this product recalled? ▼
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1673-2022.
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