Recall Z-1331-2024— D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Class II · Ongoing
Class II FDA medical device recall by D.O.R.C. Dutch Opthalmic Research Center Intl B.V., initiated 2024-01-15. It names one FDA 510(k) clearance: K213467. Product: Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 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..
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-15
- Firm location
- Zuidland, Netherlands
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.