Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Summary
The FDA issued a Class II for Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) by D.O.R.C. Dutch Opthalmic Research Center Intl B.V.. 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 di.
Details
Source
Device Recall
External ID
Z-1331-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Lot/Code Info: Product Number: 7223.ALC; UDI/DI: 08717872014173; All lots starting with a number between 2470 and 18705.
Quantity Affected: 14 boxes x 6 units per box = 84 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-15
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (D.O.R.C. Dutch Opthalmic Research Center Intl B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does D.O.R.C. Dutch Opthalmic Research Center Intl B.V. have FDA actions?
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1331-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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