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Directional Laser Probe with Alcon / Lumenis connector (25… recallZ-1332-2024 · D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · initiated Jan 15, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from D.O.R.C. Dutch Opthalmic Research Center Intl B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process control

What the company is doing

An Urgent Medical Device Recall notification letter was sent to customers on 01/15/2024. Actions to be Taken by the Customer: Pass this letter on to all those who need to be aware within your organization and/or to any organization where the potentially affected devices have been transferred to. Verify whether you have any unopened boxes, or individual pouches of the affected DORC directional laser probes in your inventory. Remove any remaining boxes and individual Products from your inventory and return the impacted Product to DORC following the instructions in the attachment. Complete, even if you do not return the Product, the on-line reply form per instructions in the attachment. In case of questions please contact us in any of the following manners: Contact your local DORC representative, or call the Customer Service at our distributor Dutch Ophthalmic, USA at 1-800-753-8824 x 1, or send an email to [email protected].

Recall details

Recall number
Z-1332-2024
Status
Open, Classified
Initiated by the company
Jan 15, 2024
Posted by the FDA
Mar 21, 2024
Recalling firm
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Quantity
21 boxes x 6 units each = 126 units
Product code
HQC
FDA submissions
K213467
Distribution
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.

Product description

Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

Code information (models, lots, serial numbers)

Product Number: 7225.ALC; UDI/DI: 08717872014203; All lots starting with a number between 2470 and 18705.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

13 devices cleared under K213467 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94022).

Sources and updates

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