Directional Laser Probe Recall Due to Fiber Extension and Direction Malfunction
A Class II medical device recall has been issued for Directional Laser Probes due to potential difficulties extending, retracting, and directing the laser fiber tip. The issue affects 126 units distributed across multiple US states.
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 is a Class II medical device recall involving a risk-of-harm surgical instrument where malfunction could impair user control during ophthalmic procedures. No illnesses or injuries have been reported. The rubric criterion applies: 'risk-of-harm products where injury has not yet been reported' receives a score of 3.
Plain-English summary
D.O.R.C. Dutch Opthalmic Research Center is recalling 126 units of its Directional Laser Probe with Alcon/Lumenis connector (25 gauge/0.5 mm, Product Number 7225.ALC) due to device malfunction issues.
Users of the affected devices may experience difficulties extending or retracting the laser fiber, and in some cases may have difficulty directing the laser fiber tip precisely. This is a Class II recall, issued by the FDA.
The affected products were distributed nationwide to Arizona, Colorado, Florida, Indiana, Maryland, North Carolina, New York, Ohio, South Carolina, Texas, and Puerto Rico. All lot numbers starting with digits between 2470 and 18705 are affected.
If you have received or are using this device, contact D.O.R.C. or the recalling agency for guidance on inspection or replacement.
The recalled product
- Product
- Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 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: 7225.ALC
- UDI/DI: 08717872014203
- 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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