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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
Related recalls
Same manufacturer · Laserex Systems Inc.
See all →- SevereLaserex Systems Recalls Ellex Tango Reflex Laser Ophthalmic Units
FDA (Devices) · 2017-06-14
Same hazard · laser exposure
See all →- HighFresh Roast ColorTrack instruments may allow excess infrared laser exposure
FDA (Devices) · 2026-06-17
- HighHeNe Laser System Allows Key Removal While Operating
FDA (Devices) · 2024-09-18
- HighHeNe Laser System Key Control Can Be Removed While Operating
FDA (Devices) · 2024-09-18
- HighRa Medical Systems Recalls DABRA Laser Due to Footswitch Defect
FDA (Devices) · 2020-12-23
- SevereZeiss Laser Scanning Microscope Component Recalled for Laser Safety Bypass
FDA (Devices) · 2020-04-15
Similar recalls
- HighIntegre Pro Laser Ophthalmoscope Systems: Risk of Unintended Laser Emission
FDA (Devices) · 2023-07-05
- ModerateEyemart Express Recalls Prescription Eyeglass Safety Lenses for Specification Failures
FDA (Devices) · 2014-11-12
- SevereLaserex Systems Recalls Ellex Tango Reflex Laser Ophthalmic Units
FDA (Devices) · 2017-06-14
- HighLumenis Vision One Laser System Recalled for Unintended Laser Exposure
FDA (Devices) · 2013-09-18
- ModerateFDA Recalls Sureflex 550 Lithotripsy Fibers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- HighAerolase LightPod ERA Lasers Recalled for Missing Remote Interlock Connector
FDA (Devices) · 2020-01-15