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Open, Classified

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

FDA Recall Z-2441-2025 · Posted 2025-08-26

Recalling FirmOrascoptic Surgical Acuity
Recall StatusOpen, Classified
Product CodeEBA
Date Initiated2025-07-03
Product Quantity10,611 units

Reason for Recall

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

Firm Action

On June 24, 2025, Orascoptic Superior Visualization issued a Urgent: Loupe Advisory Notice. On July 7, 2025 a revised letter was issued to remove cleaning instructions. On August 13, 2025, Orascoptic Superior Visualization issued an Urgent: Medical Device Recall expansion notification to include additional nose pad accessory kits and additional information on the reason for recall, the risk to patient and the steps that should be taken. Orascoptic asked consignees to take the following actions: 1. To confirm if your loupe is subject to this notice, please visit orascoptic.com website to search the serial number. " Dragonfly loupe: the serial number is printed on the inside of the right temple arm. " Phantom sport frame: the serial number is printed on the loupe case name badge plate. 2. If you have given your custom loupe to someone else, please forward a copy of this notice to that person. 3. To request a replacement nose pad that does not contain nickel, please visit orascoptic.com. 4. Visit Orascoptic.com for directions on how to replace the nose pad for your frame. Contact technical support if you need additional support at 800.369.3698. Please discard the old nose pad. 5. Acknowledge receipt of this notice and contacting Orascoptic.

Root Cause

Labeling design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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