CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report
Directional Laser Probe with Alcon / Lumenis connector recalled
D.O.R.C. Dutch Opthalmic Research Center Intl B.V is recalling Directional Laser Probe with Alcon / Lumenis connector (, distributed nationwide in the US. The recall was initiated on 15 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1333-2024
- FDA event ID
- 94022
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V, Zuidland
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jan 2024
- FDA classified
- 21 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Jan 2024 | Recall initiated by company | |
| 21 Mar 2024 | Classified by FDA | +66 days |
| 27 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Where it was distributed
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Nationwide ArizonaColoradoFloridaIndianaMarylandNorth CarolinaNew YorkOhioPuerto RicoSouth CarolinaTexas
Questions about this recall
Is Directional Laser Probe with Alcon / Lumenis connector ( recalled?
Yes. D.O.R.C. Dutch Opthalmic Research Center Intl B.V recalled Directional Laser Probe with Alcon / Lumenis connector ( on 15 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1333-2024.
Why was it recalled?
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.
Which lots are affected?
Product Number: 7227.ALC; UDI/DI: 08717872031897; All lots starting with a number between 2470 and 18705.
Where was it sold?
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from D.O.R.C. Dutch Opthalmic Research Center Intl B.V
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| Device | CLASS II | TDC Veloce" Two Dimensional Cutter - 20k CPM recalled | D.O.R.C. Dutch Opthalmic Research Center Intl B.V | Other | Nationwide |
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| Device | CLASS II | TDC Veloce" Two Dimensional Cutter - 20k CPM recalled | D.O.R.C. Dutch Opthalmic Research Center Intl B.V | Other | Nationwide |
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