FDAClass IIJuly 28, 2021

Illuminated Stepped Laser Probe Curved-for use in recall

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

Why was Illuminated Stepped Laser Probe Curved-for use in 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

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?

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

Product
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
Recalling firm
Dutch Ophthalmic USA, Inc.
Quantity
13 Boxes
Distribution
Nationwide Distribution in the states of CA, FL, MA, and UT.
Recall date
July 28, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls