Z-0527-2015Class II

Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use...

Name: Z-0527-2015 Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use...
Creator: Alcon Research, Ltd.
Published: 2014-11-11
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2014-11-11 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, Ltd. began a recall of Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX... on 2014-11-11. FDA classified it as Class II and gives the reason as "The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0527-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-11
Posted: 2014-12-12
Terminated: 2016-02-04
Recalling firm: Alcon Laboratories
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 2321
Distribution: Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
Product codes and lots: Lot numbers 061814-95 and 080614-91

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0527-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0527-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)