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Recall Observatory FDA recall evidence

Device product

Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

Z-1332-2024

January 15, 2024

Class II

Product summary

Firm
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Event
Event 94022
Status
Ongoing
Classification
Class II
Quantity
21 boxes x 6 units each = 126 units
Official record key
device-enforcement:Z-1332-2024

Official wording

Reason: 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.

Code information: Product Number: 7225.ALC; UDI/DI: 08717872014203; All lots starting with a number between 2470 and 18705.

Distribution pattern: US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.