Product Safety Recalls

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D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Recall 94022

Description: Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Recall 94022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1333-2024
Event ID94022
Event DescriptionDirectional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Quantity13 boxes x 6 units per box = 78 units
Recall ReasonWhen 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.
Device Classification20240327
Device Code InfoProduct Number: 7227.ALC; UDI/DI: 08717872031897; All lots starting with a number between 2470 and 18705.
Center Classification Date20240321
Recall Initiation Date20240115
Recalling FirmD.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Initial Notification Letter
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