Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Check against the official notice below — it lists the full affected range.
The Pentacam AXL Wave, a device used to image the front of the eye, is being recalled due to a software problem. Twenty-one systems running software versions 1.26r26 and 1.26r27 have been identified as affected. The issue causes the IOL calculator printout to frequently display inaccurate information about the alignment axis and incision position when planning toric intraocular lenses (IOLs), which are specialized lenses used in cataract surgery. The affected devices have been distributed across the United States, including multiple states and Puerto Rico.
The recall affects specific serial numbers of the Pentacam AXL Wave Model 70020, which are listed in the recall documentation. The source does not specify a remedy or corrective action for consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
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 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 Quantity: 21 systems with affected software Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.