Directional Laser Probe Recalled for Fiber Extension and Direction Difficulties
D.O.R.C. Dutch Ophthalmic Research Center is recalling Directional Laser Probes for ophthalmic surgery due to difficulties extending, retracting, and directing the laser fiber. The recall affects 84 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of surgical equipment with functional defects that could impair surgical precision and potentially lead to patient harm. No injuries have been reported in the source text, placing this in the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
D.O.R.C. Dutch Ophthalmic Research Center Intl B.V. is recalling the Directional Laser Probe with Alcon/Lumenis connector (23 gauge / 0.6 mm) due to functional defects affecting laser fiber control.
The recalled probes may experience difficulties extending or retracting the laser fiber. Users may also have difficulty directing the laser fiber tip precisely during use. These control issues could compromise surgical accuracy in ophthalmic procedures.
The recall affects 84 units (14 boxes containing 6 units each) with product number 7223.ALC and UDI/DI 08717872014173. All lots starting with numbers between 2470 and 18705 are affected. The affected devices were distributed nationwide in Arizona, Colorado, Florida, Indiana, Maryland, North Carolina, New York, Ohio, South Carolina, Texas, and Puerto Rico.
Healthcare facilities and clinicians with these devices should discontinue use of affected units immediately. Verify your device lot number against the recall range and contact D.O.R.C. Dutch Ophthalmic Research Center for replacement units or additional information.
The recalled product
- Product
- Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Number: 7223.ALC
- UDI/DI: 08717872014173
- All lots starting with a number between 2470 and 18705.
Distribution
Part of a larger recall action
This product is one of 3 recalled by D.O.R.C. Dutch Opthalmic Research Center Intl B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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