FDA-Device2024-03-27Class II
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Hazard
When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
Sold states
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Affected count
21 boxes x 6 units each = 126 units
Manufactured in
Scheijdelveweg 2, Zuidland, Netherlands
Products
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1332-2024Don't want to check this manually?
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