Alcon Custom Paks Surgical Procedure Packs recalled for cannula defects
Alcon is recalling Custom Paks Surgical Procedure Packs containing Oasis 27Ga Chang Hydrodissection Cannulas due to complaints of particulates, residue, occlusions, and bent tips in sterile cannulas used in ophthalmic surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of surgical cannulas with actual defects (particulates, residue, occlusions, bent tips) that pose risk of harm during ophthalmic procedures. No injuries or illnesses reported in source text.
Plain-English summary
Alcon Research, LLC is recalling various Custom Paks Surgical Procedure Packs containing Oasis 27Ga Chang Hydrodissection Cannulas. These surgical procedure packs are used by ophthalmic surgeons in cataract, retinal, and other eye surgeries. Approximately 57,352 cannulas are affected by this recall.
The recall was initiated due to complaints of particulates, residue, occlusions, and bent tips found in the sterile cannulas. These defects could interfere with proper surgical technique and potentially affect surgical outcomes during procedures.
The affected packs were distributed worldwide, including throughout the United States to hospitals and ambulatory surgery centers in multiple states, as well as to facilities in Australia, Canada, and New Zealand. Each facility received custom packs identified by specific Pak numbers and associated lot numbers.
Healthcare facilities that received these Custom Paks should discontinue use of affected lots immediately. Facilities should review their inventory using the provided Pak numbers and lot information to identify affected packs. Contact Alcon or consult the FDA recall notice for instructions regarding return or replacement of affected items.
The recalled product
- Product
- Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical
- Manufacturer
- Alcon Research, LLC
- Hazard
- particulates
- residue
- occlusion
- bent-tip
Distribution
Distributed nationwide across the United States.
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