Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Summary
The FDA issued a Class II for Pentacam HR REF 70900. 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-1674-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Lot/Code Info: Software version: 1.26r26 and 1.26r27 Model Number: 70900 UDI-DI Code: 04049584000026 Serial Numbers: 70900 0574 8160 70900 0925 0240 70900 0995 2250 70900 1664 8130 70900 1995 2250 70900 3451 7060 70900 3795 2250 70900 3965 1270 70900 4041 7010 70900 4172 2110 70900 4795 2250 70900 6234 7150 70900 7552 1160 70900 7952 1180 70900 8804 6140 70900 8813 3140 70900 9142 0121 70900 9695 2250 70900 9795 2250
Quantity Affected: 19 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-1674-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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