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Recall Observatory FDA recall evidence

Device product

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

Z-2097-2021

April 14, 2021

Class II

Product summary

Firm
Dutch Ophthalmic USA, Inc.
Event
Event 88146
Status
Ongoing
Classification
Class II
Quantity
13 Boxes
Official record key
device-enforcement:Z-2097-2021

Official wording

Reason: 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

Code information: Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122

Distribution pattern: Nationwide Distribution in the states of CA, FL, MA, and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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