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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Laboratories, Inc.

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 Class 2 Device Recall Alcon Laboratories, Inc.see related information
Date Initiated by FirmApril 28, 2025
Date PostedJuly 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2109-2025
Recall Event ID 96832
510(K)NumberK141065 
Product Classification Unit, phacofragmentation - Product Code HQC
ProductBrand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined 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
Code Information Lot Code: Many - See 'Attachment 1 - Affected Product List' Product Description: TOTAL PLUS PAK,23G,5.0 CPM,STDRFID Catalog Number: 8065751058 UDI-DI code: 380657510580 Lot Numbers: 1762K1 176WTW 177TVD 179EE9 179EEA Product Description: COMBINED PAK,23G,5.0 CPM,0.9STD,RFID Catalog Number: 8065751077 UDI-DI code: 380657510771 Lot Number: 178D4X Product Description: ANTERIOR PAK,0.9,W/0 PROBE/IL-LUMINATIO Catalog Number: 8065751155 UDI-DI code: 380657511556 Lot Numbers: 1782FY 1782H0 1782H1 178D4Y 178D51 178D52 178RYU 178RYV 178RYW 178RYX 1792YK 179EED 179EEE 179EEF 179EEH 179TXM 179TXN 179TXP 17AVLU 17AVLV 17C7H2 17CNRM 17CNRN 17CNRP 17CNRR 17CNRT Product Description: 23G POST TPP VAL STD 7500 Catalog Number: 8065751613 UDI-DI code: 380657516131 Lot Numbers: 1754MX 1754T1 175M41 1762K7 176CC8 176CC9 176CCA 176WU5 17769P 1782HA 1782HC 178D54 179EEJ 179TXU 17AFT8 17AVLW 17C7FX 17C7FY Product Description: TOTAL PLUS,25+ 7.5CPM VALVE Catalog Number: 8065751617 UDI-DI code: 380657516179 Lot Numbers: 1762K8 1762KD 176CCD 176WU6 17769R 1782HD 1782HE 178D56 178T0A 178T0C 179EEK 179EEL 17A4WL 17AFT9 17C7FV 17C7FW Product Description: TPP CONST 25+ SHORT 7500CPM Catalog Number: 8065751715 UDI-DI code: 380657517152 Lot Number: 1792YP Product Description: 23G CMB PAK 7.5CPM V STD 0.9 Catalog Number: 8065751765 UDI-DI code: 380657517657 Lot Numbers: 1782HJ 178D58 178T96 179302 Product Description: 25+ CMB PAK 7.5CPM,V,STD 0.9 Catalog Number: 8065751767 UDI-DI code: 380657517671 Lot Numbers: 1782HL 178DE4 178T97 179308 179EEP 179EER 179TXX 17A4WP 17AFW2 17C7FP 17C7FR Product Description: CNST ANTERIOR PK,0.9MM,W/O PROBE,BNB Catalog Number: 8065751865 UDI-DI code: 380657518654 Lot Numbers: 178DE6 178DE7 178T9A 178T9C 17930C 17930D 179EET 179EEU 17AVM3 17AVM4 17C7H8 17C7H9 17CKP5 17CKP6 17CXF0 17CXF1 Product Description: 23G CMB PAK 10K CPM,V,STD 0.9 Catalog Number: 8065752448 UDI-DI code: 380657524488 Lot Numbers: 1782J3 1782J4 178TA4 178DEH 17930J 17930K 179EH3 179EFK 179TYL 17A4XE 17AVMC 17AVMD 17AVME 17C7F2
FEI Number 1610287
Recalling Firm/
Manufacturer		 Alcon Research LLC
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information ContactKristen Kellerhals
1-817-5514047
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce89495
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HQC
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