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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1333-2024 |
Event ID | 94022 |
Event Description | Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) |
Product Type | Devices |
Distribution | US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR. |
Quantity | 13 boxes x 6 units per box = 78 units |
Recall 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. |
Device Classification | 20240327 |
Device Code Info | Product Number: 7227.ALC; UDI/DI: 08717872031897; All lots starting with a number between 2470 and 18705. |
Center Classification Date | 20240321 |
Recall Initiation Date | 20240115 |
Recalling Firm | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
Initial Notification | Letter |
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