Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head st
Summary
The FDA issued a Class II for Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, l by Orascoptic Surgical Acuity. Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction..
Details
Source
Device Recall
External ID
Z-2443-2025
Action Date
2025-09-03
Status
Ongoing
Category
device
Product Description
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Lot/Code Info: All kits manufactured between June 6, 2023 - May 14, 2025
Quantity Affected: 74 kits
Reason for Recall
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-03
Company
Orange, CA
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 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Orascoptic Surgical Acuity 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 (Orascoptic Surgical Acuity) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orascoptic Surgical Acuity have FDA actions?
Orascoptic Surgical Acuity 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-2443-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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