Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
This recall is currently active, issued March 21, 2024. It was issued by D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands.
- Recall Initiated
- January 15, 2024
- Posted
- March 21, 2024
- Recall Number
- Z-1332-2024
- Quantity
- 21 boxes x 6 units each = 126 units
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
Lot / Code Info
Product Number: 7225.ALC; UDI/DI: 08717872014203; All lots starting with a number between 2470 and 18705.
Root Cause
Process control
Action Taken
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.