Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

Recall Insight

This FDA Devices action (record #Z-1332-2024) was formally reported on March 27, 2024, with the manufacturer initiating the action on January 15, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. D.o.r.c. Dutch Opthalmic Research Center Intl B.v. is listed as the recalling firm, operating out of Zuidland. Federal records indicate 21 boxes x 6 units each = 126 units units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: 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 data in the federal record shows the product reached: US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.