Laserex Systems Recalls Ellex Medical Fixed Eye Safety Filters
Laserex Systems Inc. is recalling 74 Ellex Medical Fixed Eye Safety Filters due to a design error in the optic adaptor that may compromise eye protection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a design error that compromises eye safety, representing a risk-of-harm product where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Laserex Systems Inc. is recalling 74 units of Ellex Medical Fixed Eye Safety Filters, Model Integre S LP5532. These filters are located in the binocular mount of the laser delivery head and are designed to prevent the transmission of treatment laser light to physician eyes while keeping the aiming beam visible.
The recall was initiated because the firm discovered a design error traceable to a design change implemented in 2012 on the safety filter optic adaptor. This error may affect the filter's ability to properly block laser light, posing a potential risk to eye safety during use.
The affected units were distributed worldwide, including in the United States. Users of these filters should contact Laserex Systems Inc. for further instructions on how to address the design error.
The recalled product
- Product
- Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
- Manufacturer
- Laserex Systems Inc.
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 (1)
- Model Number : 3143270
Distribution
Distribution scope not specified by the agency.
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