Device recall: Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Class II FDA enforcement event 94022. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. started this device recall on 15 Jan 2024. The firm address in the FDA record is in Zuidland. FDA put the recall in Class II. FDA event 94022 has 3 product records. The first FDA enforcement report date is 27 Mar 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Recalling firm
D.O.R.C. Dutch Opthalmic Research Center Intl B.V., Zuidland, Netherlands.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1331-2024 | Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) | 14 boxes x 6 units per box = 84 units | Class II | Ongoing | 27 Mar 2024 |
| Z-1332-2024 | Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) | 21 boxes x 6 units each = 126 units | Class II | Ongoing | 27 Mar 2024 |
| Z-1333-2024 | Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) | 13 boxes x 6 units per box = 78 units | Class II | Ongoing | 27 Mar 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 3Median of the firm: 3
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Apr 2026 | TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311 | Device | Class II | 3 |
Official channels
- FDA enforcement report Z-1331-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 94022. https://recallregister.com/fda/ii/94022/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
- What quantity of product is in FDA event 94022?
- The event has 3 product records. The first record gives this quantity:
14 boxes x 6 units per box = 84 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.