Reported Jul 16, 2025 · Ongoing
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog…
Alcon Research LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research LLC · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- Brand NameAlcon Laboratories, Inc
- Product NameConstellation Vision System Combined
- Procedure Pak Model/Catalog NumberMany - See 'Attachment 1 -
- Affected Product List' Software VersionN/A
- Product DescriptionSurgical procedure pack to interface with Alcon Constellation Surgical console
- ComponentN/A
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Barcodes Product as published 8065751058380657510580Lot Code: Many - See 'Attachment 1 - Affected Product List' Product Description: TOTAL PLUS PAK,23G,5.0 CPM,STDRFID UDI-DI code: 380657510580 8065751077380657510771Lot Numbers: 1762K1 176WTW 177TVD 179EE9 179EEA Product Description: COMBINED PAK,23G,5.0 CPM,0.9STD,RFID UDI-DI code: 380657510771 8065751155380657511556Lot Number: 178D4X Product Description: ANTERIOR PAK,0.9,W/0 PROBE/IL-LUMINATIO UDI-DI code: 380657511556 8065751613380657516131Lot 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 UDI-DI code: 380657516131 8065751617380657516179Lot 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 UDI-DI code: 380657516179 8065751715380657517152Lot Numbers: 1762K8 1762KD 176CCD 176WU6 17769R 1782HD 1782HE 178D56 178T0A 178T0C 179EEK 179EEL 17A4WL 17AFT9 17C7FV 17C7FW Product Description: TPP CONST 25+ SHORT 7500CPM UDI-DI code: 380657517152 8065751765380657517657Lot Number: 1792YP Product Description: 23G CMB PAK 7.5CPM V STD 0.9 UDI-DI code: 380657517657 8065751767380657517671Lot Numbers: 1782HJ 178D58 178T96 179302 Product Description: 25+ CMB PAK 7.5CPM,V,STD 0.9 UDI-DI code: 380657517671 8065751865380657518654Lot Numbers: 1782HL 178DE4 178T97 179308 179EEP 179EER 179TXX 17A4WP 17AFW2 17C7FP 17C7FR Product Description: CNST ANTERIOR PK,0.9MM,W/O PROBE,BNB UDI-DI code: 380657518654 8065752448380657524488Lot 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 UDI-DI code: 380657524488 — Lot Numbers: 1782J3 1782J4 178TA4 178DEH 17930J 17930K 179EH3 179EFK 179TYL 17A4XE 17AVMC 17AVMD 17AVME 17C7F2 - Amount recalled
- 89495
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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