Product Wiki · Recalls · U.S. FDA — Device Enforcement

Directional Laser Probe with Alcon / Lumenis connector (25 gauge /… — recall Z-1332-2024

U.S. FDA — Device Enforcement · Netherlands · 2024-01-15 · Class II

As described by U.S. FDA — Device Enforcement: Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1332-2024
Date of alert
2024-01-15
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Barcode (EAN/GTIN)
08717872014203
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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