Z-1331-2024 Class II Ongoing
FDA device recall Z-1331-2024 was initiated by D.O.R.C. Dutch Opthalmic Research Center Intl B.V. on January 15, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 14 boxes x 6 units per box = 84 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2024
- Initiation Date
- January 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 boxes x 6 units per box = 84 units
Product Description
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 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 Pattern
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Code Information
Product Number: 7223.ALC; UDI/DI: 08717872014173; All lots starting with a number between 2470 and 18705.