FDA Recall Open, Classified

Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP

Recall: Z-1291-2023 · Initiated March 10, 2023

Recall

Recall Number: Z-1291-2023
Event Number: 91878
Firm: Alcon Research, LLC
FEI Number: 1000117501
Product Code: LRO
Status: Open, Classified
Root Cause: Employee error
Initiated: March 10, 2023
Posted: March 28, 2023
Address: 9965 Buffalo, Speedway Houston, TX, 77054-1309

Description

Reason

Sterility; Steril surgical procedure packs contain incomplete seals.

Action

On March 10, 2023 Alcon issued a "Urgent: Voluntary Medical Device Removal" letter to affected consignees. In addition to notifying consignees about the recall product, they ask consignees to take the following actions: 1. Review your inventory to determine if you have any unused affected product within your facility. See table on page 1 for affected Custom Pak lots. 2. Segregate any unused affected product from your inventory. 3. An Alcon associate will reach out to you directly to arrange for the return and replacement of your affected inventory of Alcon Custom Pak. 4. Fill out the attached Response Form , even if you have zero (0) units remaining in inventory and return the form to Alcon using the contact information provided on the form. 5. Please forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred. 6. In the event you have experienced adverse events or product quality issues related to this communication, please contact Alcon via web (https://notifeye.alcon.com), by email ([email protected]) or by phone (1-800-757-9780, Option 5). 7. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA MedWatch Adverse Event Reporting program either online (FDA EMAIL), by regular mail or by fax: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm

Distribution

US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None

Quantity

1035 packs