FDA Medical Device Recalls (openFDA)
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.: Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
- Recall number
- Z-1332-2024
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- Product
- Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
- Status
- Open, Classified
- Initiated
- 2024-01-15
- Posted
- 2024-03-21
- Terminated
- not on file
- Reason
- When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
- Root cause
- Process control
- Action
- An Urgent Medical Device Recall notification letter was sent to customers on 01/15/2024. Actions to be Taken by the Customer: Pass this letter on to all those who need to be aware within your organization and/or to any organization where the potentially affected devices have been transferred to. Verify whether you have any unopened boxes, or individual pouches of the affected DORC directional laser probes in your inventory. Remove any remaining boxes and individual Products from your inventory and return the impacted Product to DORC following the instructions in the attachment. Complete, even if you do not return the Product, the on-line reply form per instructions in the attachment. In case of questions please contact us in any of the following manners: Contact your local DORC representative, or call the Customer Service at our distributor Dutch Ophthalmic, USA at 1-800-753-8824 x 1, or send an email to TSC@dorcglobal.com.
- Quantity
- 21 boxes x 6 units each = 126 units
- Distribution
- US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
- Lot, serial or model codes
- Product Number: 7225.ALC; UDI/DI: 08717872014203; All lots starting with a number between 2470 and 18705.
- 510(k) numbers
- ["K213467"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 3002806863
- Firm city
- Zuidland
- Firm state
- not on file
- Firm country
- Netherlands
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