Alcon Custom Ophthalmic Surgical Procedure Packs

FDA device recall Z-1328-2021 · posted 2021-04-01 · Terminated

Recall details

Recalling firm

Alcon Research, LLC

Reason for recall

Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.

Action taken

On February 2, 2021 Alcon issued an :Urgent: Voluntary Medical Device Removal letter via FedEx mail to all affected consignees. On February 12, 2021 and April 9, 2021, Alcon expanded their recall to additional lots and consignees. On June 14, 2021, Alcon expanded their recall and issued an URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION (FIELD ACTION EXPANSION) letter to affected consignee via FedEx. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Forward this notification to all departments or organizations using your Custom Pak. 2. See list (Table 1) of affected Alcon Custom Pak lots that were or will be distributed to your facility. You may receive Custom Pak lots assembled prior to this Field Correction notification, and as a result, you may be receiving affected inventory in future shipments. If you receive any affected Alcon Custom Pak lots in the future, they will be identified with the one of the following stickers: A. "ATTENTION DISCARD ENCLOSED GOWNS REPLACE WITH INDIVIDUALLY WRAPPED STERILE GOWSNS" or B. "URGENT FIELD CORRECTION Discard Enclosed Gowns Replace with individually wrapped sterile gowns" 3. Review your inventory of Alcon Custom Pak lots against the attached table. For Custom Pak in your inventory, affix the provided stickers directly to the outside of your identified affected Custom Pak units in a location most easily seen for your facility. NOTE: Alcon Custom Pak units and standalone gowns are sterile and should not be opened prior to surgery. 4. Upon opening of your identified Alcon Custom Pak for surgical use, remove and dispose of the enclosed surgical gowns. 5. Use separate sterile standalone surgical gowns, either your own inventory or those supplied by Alcon. 6. Please complete the attached Response Form indicating your understanding of the included instructions. 7. Return the attached Response Form via fax or email to Alcon. 8. Keep Table 1 for your rec

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRO

Quantity affected

249,853 Custom Packs

Distribution

Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand

Date initiated

2021-02-02

Date posted

2021-04-01

Date terminated

2023-06-30

Location

Houston, TX

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