Alcon Research, Ltd.: Medical Device Recall in 2014 - (Recall #: Z-0527-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 11, 2014

Date Posted: December 17, 2014

Recall Number: Z-0527-2015

Event ID: 69743

Reason for Recall:

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

Status: Terminated

Product Quantity: 2321

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.

Voluntary or Mandated:

Voluntary: Firm initiated