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Recall Observatory FDA recall evidence

Device 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.

Z-0527-2015

November 11, 2014

Class II

Product summary

Firm
Alcon Research, Ltd.
Event
Event 69743
Status
Terminated
Classification
Class II
Quantity
2321
Official record key
device-enforcement:Z-0527-2015

Official wording

Reason: The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

Code information: Lot numbers 061814-95 and 080614-91

Distribution pattern: Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.