FDA Medical Device Recalls (openFDA)
Dutch Ophthalmic USA, Inc.: Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
- Recall number
- Z-2097-2021
- Recalling firm
- Dutch Ophthalmic USA, Inc.
- Product
- Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
- Status
- Open, Classified
- Initiated
- 2021-04-14
- Posted
- not on file
- Terminated
- not on file
- 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
- 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 d.clement@dorcglobal.com. " 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
- 13 Boxes
- Distribution
- Nationwide Distribution in the states of CA, FL, MA, and UT.
- Lot, serial or model codes
- Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122
- 510(k) numbers
- ["K031023"]
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 3007916166
- Firm city
- Exeter
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28