Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
FDA device recall Z-1332-2024 · posted 2024-03-21 · Open, Classified
Recall details
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HQC
- Quantity affected
- 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.
- Date initiated
- 2024-01-15
- Date posted
- 2024-03-21
- Location
- Zuidland, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVA NEXUS Ophthalmic Surgical System (K213467) | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022-06-14 |