Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Nu

FDA device recall Z-2108-2025 · posted 2025-07-10 · Open, Classified

Recall details

Recalling firm

Alcon Research LLC

Reason for recall

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

Action taken

On 05/01/2025, the firm sent via Overnight FedEx an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that there is a potential for some trays within impacted lots to have damage in the Tyvek cover and compromising the sterility of the products. Customers are instructed: For Standalone Constellation kits- 1. Review inventory to locate, segregate and dispose of affected products 2. Call Alcon Customer Service to arrange for replacement products 3. Forward Post Recall Notice to all department within their organization and to facilities where the product may have been transfer to 4. Post the Recall Notice on or near affected products to ensure awareness of the recall. Alcon will be reinspecting its remaining inventory. Reinspected products that pass inspection will be labeled with a green "QC PASSED" sticker on the packaging. For all Custom Pak kits that contain an impacted Constellation Pak, customers are instructed to: 1. All components inside a Custom Pak are terminal sterilized and Alcon is advising that after an affected Custom Pak is opened, the affected Constellation Pak should be used for that specific surgical case and discarded at the end of the case. Do not save the Constellation Pak for future use. 2. Review their inventory and any unused Customer Pak that contain the affected Constellation Pak, and place the provided stickers to label any affected products. 3. If customer have previously reshelved any affected Constellation Pak, please dispose of them. Any questions or concerns about this matter, call Alcon Customer Service at 1-800-862-5266 or contact your Alcon Sales Representative.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MLZ

Quantity affected

198205

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV,

Date initiated

2025-04-28

Date posted

2025-07-10

Location

Fort Worth, TX

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