Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Summary
The FDA issued a Class II for Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. by Oculus Optikgeraete GMBH. Reason: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs.
Details
Source
Device Recall
External ID
Z-1672-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
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
Quantity Affected: 21 systems with affected software
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-08
Company
Wetzlar
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Oculus Optikgeraete GMBH has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oculus Optikgeraete GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oculus Optikgeraete GMBH have FDA actions?
Oculus Optikgeraete GMBH has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1672-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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