FDA Device Intelligence
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Accessories, Soft Lens Products

FDA product code LPN · Class 2 · Ophthalmic

204
Registered devices
8,010
Adverse events
23
Recalls
121
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-06-23Family Dollar Stores, Llc.Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2022-06-23Family Dollar Stores, Llc.Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2022-06-23Family Dollar Stores, Llc.Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot
2020-12-29Allergan PLCMissing Instruction For Use insert.
2016-09-19Bausch & Lomb Inc IrbProduct was found to contain excess residual levels of hydrogen peroxide.
2011-02-21Marietta VisionProduct is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico.
2010-07-23Abbott Medical Optics Inc (AMO)The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions ma
2010-07-23Abbott Medical Optics Inc (AMO)The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions ma
2009-08-17Bausch & Lomb IncDuring routine testing the product failed to meet shelf life specifications.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.