Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
This recall is currently active, issued August 26, 2025. It was issued by Orascoptic Surgical Acuity.
- Company
- Orascoptic Surgical Acuity
- Recall Initiated
- July 3, 2025
- Posted
- August 26, 2025
- Recall Number
- Z-2444-2025
- Quantity
- 743 kits
- Firm Location
- Orange, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
All kits manufactured between June 6, 2023 - May 14, 2025
Root Cause
Labeling design
Action Taken
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.