FDA recall Z-1333-2024

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Class II · device

Product

Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2024-01-15
Report date: 2024-03-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Zuidland, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1333-2024