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.
FDA Recall Z-0527-2015 · Posted 2014-12-12
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Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeGEI
Date Initiated2014-11-11
Date Terminated2016-02-04
Product Quantity2321
Reason for Recall
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
Firm Action
On November 11, 2014, the firm sent letters to their customers notifiying them of the medical device recall. The recalling firm asked their customers to stop using the recalled product, remove it from inventory, return the affected product, and complete a response form.
Root Cause
Process control
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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