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PuriLens Plus Disinfecting System
LIFESTYLE CO INC, THE · Model MS0610/H · UDI-DI 00830002000063
10
510(k) clearances
8,010
Adverse events (2 deaths)
23
Recalls
32
Facilities
Description
Starter Kit contents: Electrical voltage adapter, PuriLens Unit, removable cleaning/disinfecting chamber, two 4-oz. (120-mL) bottles PuriLens Plus Preservative-free Saline, instruction booklet.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2020-12-29 | Allergan PLC | Missing Instruction For Use insert. |
| 2016-09-19 | Bausch & Lomb Inc Irb | Product was found to contain excess residual levels of hydrogen peroxide. |
| 2011-02-21 | Marietta Vision | Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico. |
| 2010-07-23 | Abbott 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 may leak and, although |
| 2010-07-23 | Abbott 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 may leak and, although |
| 2009-08-17 | Bausch & Lomb Inc | During routine testing the product failed to meet shelf life specifications. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.