PlainRecalls
FDA Devices Moderate Class II Ongoing

Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

Reported: March 27, 2024 Initiated: January 15, 2024 #Z-1331-2024

Product Description

Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

Reason for Recall

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.

Details

Units Affected
14 boxes x 6 units per box = 84 units
Distribution
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Location
Zuidland

Frequently Asked Questions

What product was recalled?
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm). Recalled by D.O.R.C. Dutch Opthalmic Research Center Intl B.V.. Units affected: 14 boxes x 6 units per box = 84 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1331-2024.