Z-2097-2021Class II

Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system

Name: Z-2097-2021 Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system
Creator: Dutch Ophthalmic USA, Inc.
Published: 2021-04-14
License: https://open.fda.gov/license/

Dutch Ophthalmic USA, Inc. / initiated 2021-04-14 / Open, Classified / root cause: manufacturing process

FDA source

Dutch Ophthalmic USA, Inc. began a recall of Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC on 2021-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2097-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-14
Posted: 2021-07-20
Recalling firm: Dutch Ophthalmic USA, Inc.
Product: Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
Product code: HQF Laser, Ophthalmic
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 13 Boxes
Distribution: Nationwide Distribution in the states of CA, FL, MA, and UT.
Product codes and lots: Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2097-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2097-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-19

Product code HQF

K031023Class IIPeregrine Illuminating Laser Probe Model Pd600.10Peregrine Surgical , Ltd. / cleared 2003-06-27

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)