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RecallWatchMedical Device Safety
Class IIOngoingZ-2108-2025

Alcon Research LLC recalls Brand Name: Alcon Laboratories

Alcon Research LLCFort Worth, TX, United StatesReported Jul 16, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component:N/A
    UDI-DI codeCatalog # Number
    344 affected lots
    20K8065000093380650000934177FE41782JM178DEX178TCV179EP4
    +336 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

What the firm is doing

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.

DistributionShow details

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, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macao, Malaysia, Malta, Mexico, Moldova, Mongolia, Montenegro, Morocco, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Qatar, Republic of North Macedonia, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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