FDAClass IINovember 15, 2023

Alcon Custom-Pak recall

Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

Why was Alcon Custom-Pak recalled?

Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOT # : 160NMU, UDI: (01)10380653302278

Product
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Recalling firm
Alcon Research, LLC
Quantity
120 packs
Distribution
US: VA OUS: None
Recall date
November 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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