Recall Z-1332-2024 ยท HQC Unit, Phacofragmentation
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
| Date | Mar 21, 2024 (initiated Jan 15, 2024) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213467 | EVA NEXUS Ophthalmic Surgical System D.O.R.C. Dutch Ophthalmic Research Center (International), Jun 14, 2022 |