FDAClass IIMarch 27, 2024

Directional Laser Probe with Alcon / Lumenis connector recall

Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

Why was Directional Laser Probe with Alcon / Lumenis connector 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number: 7227.ALC; UDI/DI: 08717872031897; All lots starting with a number between 2470 and 18705.

Product
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Recalling firm
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Quantity
13 boxes x 6 units per box = 78 units
Distribution
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Recall date
March 27, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls