Alcon Single-Use Iris Bipolar Forceps Recalled for Lack of Sterilization
Alcon Research, Ltd. is recalling single-use iris bipolar forceps labeled as sterile but not sterilized prior to shipment.
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: The recall involves a medical device that was not sterilized as labeled, creating a risk of infection or harm during surgery. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research, Ltd. is recalling 2,321 units of Single-Use Curved Jewelers/Iris Bipolar Forceps (REF 8065129101) and Single-Use Straight/Iris Bipolar Forceps (REF 8065129501). These electrosurgical instruments are used in ophthalmic surgery and are labeled as ethylene oxide (EO) sterilized. The recall is due to the fact that the units were not sterilized prior to shipment to customers.
The affected products are identified by lot numbers 061814-95 and 080614-91. The products were distributed worldwide, including the United States (nationwide) and Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
Healthcare providers and patients should stop using these specific forceps immediately. Users should contact Alcon Research, Ltd. for instructions on returning the products or obtaining replacements.
The recalled product
- Product
- Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 2,321
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers 061814-95 and 080614-91
Distribution
Distributed nationwide across the United States.
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