Lacrimedics Recalls VisiPlugST Devices Due to Moisture-Related Breakage
Lacrimedics Inc is recalling VisiPlugST devices because moisture levels may cause the plugs to break apart or crumble upon contact.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the source text does not report any injuries or illnesses.
Plain-English summary
Lacrimedics Inc is recalling VisiPlugST for the Lacrimal Efficiency Test, also sold in the EU as CollaSyn Plugs. The recall involves model numbers 1813, 1814, 1815, 1903, 1904, and 1905. These cylindrical devices are approximately 1.75-2.00mm in length and are available in three sizes: 0.3mm, 0.4mm, and 0.5mm. The affected units are packaged in foil pouches and are intended to be placed in the upper and/or lower horizontal canaliculus.
The recall is being conducted because moisture levels may cause the VisiPlugST or CollaSyn Plugs to break apart or crumble upon contact. Additionally, the firm's data suggests that a 4-year shelf life may not be sustained for these devices.
The recall covers 781 units distributed worldwide, including nationwide distribution in the United States and specific countries such as Australia, Brazil, the Czech Republic, France, Ireland, Mexico, Peru, Switzerland, and the United Kingdom. Specific lot numbers and expiration dates are listed in the agency's recall record. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. P
- Manufacturer
- Lacrimedics Inc
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 781
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- LOT numbers: 072314-2328
- 072314-2329
- 072314-2330
- 081314-2365
- 081314-2366
- 081314-2367
- 091814-2345
- 091814-2350
- 100614-2344
- EXPIRATION DATES: 2018-05-15
- 2018-07-23
- 2018-08-13
- 2018-08-14
- 2018-09-14
- 2018-09-25
- 2018-10-06
Distribution
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