Class 2 Device Recall Directional Laser Probes

• Date Initiated by Firm: January 15, 2024
• Date Posted: March 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1332-2024
• Recall Event ID: 94022
• 510(K)Number: K213467
• Product Classification: Unit, phacofragmentation - Product Code HQC
• Product: Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
• Code Information: Product Number: 7225.ALC; UDI/DI: 08717872014203; All lots starting with a number between 2470 and 18705.
• Recalling Firm/ Manufacturer: D.O.R.C. Dutch Opthalmic Research Center Intl B.V.; Scheijdelveweg 2; Zuidland Netherlands
• For Additional Information Contact: Customer Service; 800-7538824 Ext. 1
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HQC