Z-1643-2009

Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by...

Name: Z-1643-2009 Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by...
Creator: Alcon Laboratories, Inc
Published: 2009-04-29
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2009-04-29 / Terminated / root cause: manufacturing process

FDA source

Alcon Laboratories, Inc began a recall of Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134 on 2009-04-29. The reason FDA records is "Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades". 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-1643-2009
Status: Terminated
Initiated: 2009-04-29
Posted: 2009-05-26
Terminated: 2009-10-14
Recalling firm: Alcon Laboratories
Product: Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
Product code: NGY Cannula, Trocar, Ophthalmic
Reason for recall: Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance.
Quantity in commerce: 3,523 surgical paks.
Distribution: Worldwide Distribution -- USA and Canada.
Product codes and lots: Lot #9013991X, 9014291X and 9014509X.

Product code NGY

K911808Class IIGemini Ophthalmic Surgery SystemAlcon Laboratories / cleared 1991-06-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)