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