Directional Laser Probe Recalled for Fiber Extension and Direction Failure
D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.
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: This Class II medical device recall involves a mechanical failure in a surgical instrument (difficulty extending/retracting and directing the laser fiber) with potential for patient harm. No injuries or illnesses have been reported to date, placing this within the 'risk-of-harm products where injury has not yet been reported' category per FDA severity criteria.
Plain-English summary
D.O.R.C. Dutch Ophthalmic Research Center International B.V. is recalling Directional Laser Probes with Alcon/Lumenis connector (27 gauge / 0.4 mm) due to a mechanical defect affecting fiber control.
The affected devices may experience difficulties when extending or retracting the laser fiber. Additionally, users may encounter difficulties directing the laser fiber tip precisely. These control issues could potentially compromise surgical precision during ophthalmic procedures.
The recall affects 78 units (13 boxes × 6 units per box) with product number 7227.ALC and UDI/DI 08717872031897. All lots starting with a number between 2470 and 18705 are affected. Distribution was nationwide across Arizona, Colorado, Florida, Indiana, Maryland, North Carolina, New York, Ohio, South Carolina, Texas, and Puerto Rico.
Affected facilities should discontinue use of the recalled devices and contact D.O.R.C. Dutch Ophthalmic Research Center International B.V. regarding return or replacement of the affected units.
The recalled product
- Product
- Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 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: 7227.ALC
- UDI/DI: 08717872031897
- 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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