FDA Medical Device Recalls (openFDA)
Alcon Research, Ltd.: 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.
- Recall number
- Z-0527-2015
- Recalling firm
- Alcon Research, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2014-11-11
- Posted
- 2014-12-12
- Terminated
- 2016-02-04
- Reason
- The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
- 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
- 2321
- Distribution
- Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
- Lot, serial or model codes
- Lot numbers 061814-95 and 080614-91
- 510(k) numbers
- ["K880863","K934320"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28