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Illuminated Stepped Laser Probe Curved-for use in… recallZ-2097-2021 · Dutch Ophthalmic USA, Inc. · initiated Apr 14, 2021

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 Dutch Ophthalmic USA, Inc. 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

Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

FDA root cause category: Process control

What the company is doing

Dutch Ophthalmic issued Urgent Medical Device Recall letter on 4/14/21 via Certified Mail. Letter states reason for recall, health risk and action to take: Verify whether you have unused boxes of LOT 039406 in your inventory and quarantine product subject to this safety notice. " If returned contact Customer Service at Dutch Ophthalmic, USA at 1-800-753- 8824 x 1 to receive a Return Material Authorization (RMA) number and receive instructions on how to return unused boxes of the impacted product. " If not returning, verify that expiry dates in any hospital system are showing the correct expiry date of 2024- 10-01. If not, please ensure the expiry date is modified to reflect the actual expiry date. " For opened boxes of LOT 039406, verify that expiry dates in any hospital system are showing the correct expiry date of 2024-10-01. If not, please ensure the expiry date is modified to reflect the actual expiry date. Complete the attached Urgent Medical Device Safety Notice Reconciliation Form, sign it and return a scan or photo of the signed form by email to [email protected]. " Add the original completed and signed Urgent Medical Device Safety Notice Reconciliation Form referencing the Return Material Authorization number with the product to be returned. In the next days our sales representative will contact you to discuss replacement of the to be returned boxes and to verify whether there are additional questions or actions in which we can assist. If in the meantime you need any further information or support concerning this issue, please contact our local representative at Dutch Ophthalmic USA at 1-800-753-8824 x 1 for assistance.

Recall details

Recall number
Z-2097-2021
Status
Open, Classified
Initiated by the company
Apr 14, 2021
Recalling firm
Dutch Ophthalmic USA, Inc.
Quantity
13 Boxes
Product code
HQF
FDA submissions
K031023
Distribution
Nationwide Distribution in the states of CA, FL, MA, and UT.

Product description

Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

Code information (models, lots, serial numbers)

Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122

Devices named in this recall

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

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page