Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURG
FDA device recall Z-1291-2023 · posted 2023-03-28 · Open, Classified
Recall details
- Recalling firm
- Alcon Research, LLC
- Reason for recall
- Sterility; Steril surgical procedure packs contain incomplete seals.
- Action taken
- 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 (msus.safety@alcon.com) 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
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 1035 packs
- Distribution
- US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None
- Date initiated
- 2023-03-10
- Date posted
- 2023-03-28
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALCON SURGICAL PROCEDURE PACKS (K880961) | Alcon Laboratories | 1988-04-29 |