D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

Recall date

January 15, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1332-2024

FDA classification

Class II

Brand / firm

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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