FDA Enforcement
Class II
Ongoing
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
Recall: Z-1332-2024
·
Reported March 27, 2024
Enforcement
- Recall Number
- Z-1332-2024
- Event ID
- 94022
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 27, 2024
- Initiation Date
- January 15, 2024
- Classification Date
- March 21, 2024
- Address
- Scheijdelveweg 2, Zuidland, N/A, Netherlands
Description
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
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.
Code Info
Product Number: 7225.ALC; UDI/DI: 08717872014203; All lots starting with a number between 2470 and 18705.
Distribution
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Quantity
21 boxes x 6 units each = 126 units