Z-1333-2024Class II

Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

Name: Z-1333-2024 Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Creator: D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Published: 2024-01-15
License: https://open.fda.gov/license/

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. / initiated 2024-01-15 / Open, Classified / root cause: manufacturing process

FDA source

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. began a recall of Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) on 2024-01-15. FDA classified it as Class II and gives the reason as "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". 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-1333-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-15
Posted: 2024-03-21
Recalling firm: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product: Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Product code: HQC Unit, Phacofragmentation
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 13 boxes x 6 units per box = 78 units
Distribution: US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Product codes and lots: Product Number: 7227.ALC; UDI/DI: 08717872031897; All lots starting with a number between 2470 and 18705.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1333-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1331-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-21
Z-1332-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-21
Z-1333-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-21

Product code HQC

K213467Class IIEVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) / cleared 2022-06-14

MDM coverage of this record lists here, newest first.

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)