{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2108-2025.jsonld", "@type": "schema:Dataset", "name": "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", "description": "FDA recall Z-2108-2025 — Alcon Research LLC is recalling 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 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2108-2025&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "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", "manufacturer": { "@type": "schema:Organization", "name": "Alcon Research LLC" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2108-2025/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-2108-2025: Alcon Research LLC is recalling 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", "text": "The FDA logged enforcement record Z-2108-2025: Alcon Research LLC is voluntarily recalling 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 — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-28. Affected lots/codes: Lot Code: Many - See 'Attachment 1 - Affected Product List' Product Description: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU Catalog Number: 8065000093 UDI-DI code: 380650000934 Lot Numbers: 177FE4 1782JM 178DEX 178TCV 179EP4 179EP3 179U0P 17AVMM 17AVMN 17AVML 17AVMP Product Description: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000095 UDI-DI code: 380650000958 Lot Numbers: 1782JU 1782JT 178DF2 178TCY 178TD0 1792YF 1792YE 179U0R 17A4XT 17A4XU 17AFXT 17AVMT 17AVMU 17AVMV 17AVMW 17AVMX 17CNVC Product Description: 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000096 UDI-DI code: 380650000965 Lot Numbers: 1782JV 178DF4 17A4XV Product Description: TOTAL PLUS,23G,10K VALVE STD Catalog Number: 8065752435 UDI-DI code: 380657524358 Lot Numbers: 1754N7 1754NC 175M43 1762KH 176CCJ 176CCK 176WU8 176WU9 17769X 1782HM 1782HN 178T9K 179EEV 179TY3 179TY4 17A4WX 17C7FM 17C7FL Product Description: TOTAL PLUS,23GA,10K VALVE WD Catalog Number: 8065752436 UDI-DI code: 380657524365 Lot Numbers: 1762KJ 176WUA 17769Y 177FDH 1782HP 178DE8 178T9N 179EEX 179EEY 17C7FK Product Description: TOTAL PLUS,25+,10K VALVE STD Catalog Number: 8065752437 UDI-DI code: 380657524372 Lot Numbers: 1754NK 1754NL 1754NM 1754TC 1754TD 1754TE 1754TF 1754TH 175M45 175M46 175M47 175M44 1762KK 1762KL 1762KM 1762KN 176CCR 176CCL 176CCM 176CCN 176CCP 176WUD 1776A4 1776A5 1776A6 177FDJ 177FDK 177FDL 177FDM 177TUP 177TUR 177TUT 1782HU 1782HV 1782HW 178DEA 178DEC 178T9V 178T9W 178TD4 17930F 17930H 179EF3 179EF2 179TY6 179TY7 179TY8 179TY9 179TYA 179TYC 179TYD 17A4X5 17A4X6 17A4X2 17A4X3 17A4X1 17AFWE 17AFWH 17AFWP 17AFWR 17AFWY 17AFX0 17AFWX 17C7FD 17C7FE Product Description: TOTAL PLUS,25+,10K VALVE WD Catalog Number: 8065752438 UDI-DI code: 380657524389 Lot Numbers: 175M48 1762KR 1762KT 176CCT 176WUE 1776AD 177FDN 1782HY 178TA1 178TA2 178TA3 179EF6 179EF7 179TYJ 17A4X9 17AFX6 17C7FC 17CNUT Product Description: TOTAL PLUS,27+,10K VALVE STD Catalog Number: 8065752439 UDI-DI code: 380657524396 Lot Numbers: 176CCU 1776AE Product Description: 23G CMB PAK 10K CPM,V,WA 0.9 Catalog Number: 8065752449 UDI-DI code: 380657524495 Lot Numbers: 178DEK 178DEL 179TYM 17A4XF 17C7E9 Product Description: 25+ CMB PAK 10K CPM,V,STD 0.9 Catalog Number: 8065752450 UDI-DI code: 380657524501 Lot Numbers: 1782J7 1782J8 1782J5 1782J9 178DEN 178DEP 178TCN 178TCP 17930L 17930M 17930N 178TCR 179EHF 179EHJ 179TYW 179U07 179U02 17A4XH 17A4XP 17AFXF 17AFXA Product Description: 25+ CMB PAK 10K CPM,V,WA 0.9 Catalog Number: 8065752451 UDI-DI code: 380657524518 Lot Numbers: 1782JL 178DER 1792YH 178TCU 179U0K 17A4XR Product Description: 25+TTLPL VPK 20000CPM BEV VAL Catalog Number: 8065753106 UDI-DI code: 380657531066 Lot Numbers: 174P7C 1754RP 1754RR 1754RT 1754RU 175M4N 175M4P 175M4M 1754UY 175M4R 175M4T 175M4U 1762LL 1762LR 1762LP 1762LT 1762LM 1762LN 176CD7 176CD6 176NFD 176NFE 176NFH 176NFJ 176WUW 176WUX 176WV0 176WV1 1776DD 1776DC 177FEF 177FEH 177FEJ 177TVF 177TVH 1782K0 1782K1 1782K2 1782K3 1782K4 178DFW 178DFX 178DFY 178DH0 178RTD 178TD1 178TD2 178TD3 1792YD 179EPE 179EPF 179EPH 179EPJ 179EPK 179EPL 179EPM 179EPN 179EPP 179U14 179U15 179U16 179U17 17A4YP 17A4YM 17A4YN 17A4YR 17AVN6 17AVN9 17AVN7 17AVNE 17C7DW 17C7DX 17C7DY 17C7E0 Product Description: 27+TTLPL VPK 20000CPM BEV VL Catalog Number: 8065753109 UDI-DI code: 380657531097 Lot Numbers: 1762LV 1762LW 1762LX 178DHL 179EPT 179EPU Product Description: 25+ TTL PLUS VPAK 20000CPM BWV Catalog Number: 8065830077 UDI-DI code: 380658300777 Lot Numbers: 1754RH 1754RJ 1754RK 1754RL 1754UW 1754UX 175M4H 175M4J 175M4K 175M4L 1762LH 1762LK 1762LJ 176WUU 176WUV 1776DA 177FEA 177FEC 177TV9 177TVA 1782JW 1782JX 178DF7 178DF8 178DF9 178DFA 178RTC 179EPA 179EPC 179U0V 179U0W 179U0Y 17A4XX 17A4XW 17AVN2 17C7E6 17C7E4 17C7E2 17C7E3 17C7E5. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2108-2025&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2108-2025&lang=eng" } }, "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2108-2025/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-2108-2025 as Class II", "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2108-2025&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2108-2025&lang=eng" } }, "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2108-2025/boundary", "@type": "schema:Claim", "name": "What an FDA recall is — and is NOT", "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-2108-2025", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-2108-2025", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Alcon Research LLC", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "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.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-04-28", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Lot Code: Many - See 'Attachment 1 - Affected Product List' Product Description: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU Catalog Number: 8065000093 UDI-DI code: 380650000934 Lot Numbers: 177FE4 1782JM 178DEX 178TCV 179EP4 179EP3 179U0P 17AVMM 17AVMN 17AVML 17AVMP Product Description: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000095 UDI-DI code: 380650000958 Lot Numbers: 1782JU 1782JT 178DF2 178TCY 178TD0 1792YF 1792YE 179U0R 17A4XT 17A4XU 17AFXT 17AVMT 17AVMU 17AVMV 17AVMW 17AVMX 17CNVC Product Description: 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000096 UDI-DI code: 380650000965 Lot Numbers: 1782JV 178DF4 17A4XV Product Description: TOTAL PLUS,23G,10K VALVE STD Catalog Number: 8065752435 UDI-DI code: 380657524358 Lot Numbers: 1754N7 1754NC 175M43 1762KH 176CCJ 176CCK 176WU8 176WU9 17769X 1782HM 1782HN 178T9K 179EEV 179TY3 179TY4 17A4WX 17C7FM 17C7FL Product Description: TOTAL PLUS,23GA,10K VALVE WD Catalog Number: 8065752436 UDI-DI code: 380657524365 Lot Numbers: 1762KJ 176WUA 17769Y 177FDH 1782HP 178DE8 178T9N 179EEX 179EEY 17C7FK Product Description: TOTAL PLUS,25+,10K VALVE STD Catalog Number: 8065752437 UDI-DI code: 380657524372 Lot Numbers: 1754NK 1754NL 1754NM 1754TC 1754TD 1754TE 1754TF 1754TH 175M45 175M46 175M47 175M44 1762KK 1762KL 1762KM 1762KN 176CCR 176CCL 176CCM 176CCN 176CCP 176WUD 1776A4 1776A5 1776A6 177FDJ 177FDK 177FDL 177FDM 177TUP 177TUR 177TUT 1782HU 1782HV 1782HW 178DEA 178DEC 178T9V 178T9W 178TD4 17930F 17930H 179EF3 179EF2 179TY6 179TY7 179TY8 179TY9 179TYA 179TYC 179TYD 17A4X5 17A4X6 17A4X2 17A4X3 17A4X1 17AFWE 17AFWH 17AFWP 17AFWR 17AFWY 17AFX0 17AFWX 17C7FD 17C7FE Product Description: TOTAL PLUS,25+,10K VALVE WD Catalog Number: 8065752438 UDI-DI code: 380657524389 Lot Numbers: 175M48 1762KR 1762KT 176CCT 176WUE 1776AD 177FDN 1782HY 178TA1 178TA2 178TA3 179EF6 179EF7 179TYJ 17A4X9 17AFX6 17C7FC 17CNUT Product Description: TOTAL PLUS,27+,10K VALVE STD Catalog Number: 8065752439 UDI-DI code: 380657524396 Lot Numbers: 176CCU 1776AE Product Description: 23G CMB PAK 10K CPM,V,WA 0.9 Catalog Number: 8065752449 UDI-DI code: 380657524495 Lot Numbers: 178DEK 178DEL 179TYM 17A4XF 17C7E9 Product Description: 25+ CMB PAK 10K CPM,V,STD 0.9 Catalog Number: 8065752450 UDI-DI code: 380657524501 Lot Numbers: 1782J7 1782J8 1782J5 1782J9 178DEN 178DEP 178TCN 178TCP 17930L 17930M 17930N 178TCR 179EHF 179EHJ 179TYW 179U07 179U02 17A4XH 17A4XP 17AFXF 17AFXA Product Description: 25+ CMB PAK 10K CPM,V,WA 0.9 Catalog Number: 8065752451 UDI-DI code: 380657524518 Lot Numbers: 1782JL 178DER 1792YH 178TCU 179U0K 17A4XR Product Description: 25+TTLPL VPK 20000CPM BEV VAL Catalog Number: 8065753106 UDI-DI code: 380657531066 Lot Numbers: 174P7C 1754RP 1754RR 1754RT 1754RU 175M4N 175M4P 175M4M 1754UY 175M4R 175M4T 175M4U 1762LL 1762LR 1762LP 1762LT 1762LM 1762LN 176CD7 176CD6 176NFD 176NFE 176NFH 176NFJ 176WUW 176WUX 176WV0 176WV1 1776DD 1776DC 177FEF 177FEH 177FEJ 177TVF 177TVH 1782K0 1782K1 1782K2 1782K3 1782K4 178DFW 178DFX 178DFY 178DH0 178RTD 178TD1 178TD2 178TD3 1792YD 179EPE 179EPF 179EPH 179EPJ 179EPK 179EPL 179EPM 179EPN 179EPP 179U14 179U15 179U16 179U17 17A4YP 17A4YM 17A4YN 17A4YR 17AVN6 17AVN9 17AVN7 17AVNE 17C7DW 17C7DX 17C7DY 17C7E0 Product Description: 27+TTLPL VPK 20000CPM BEV VL Catalog Number: 8065753109 UDI-DI code: 380657531097 Lot Numbers: 1762LV 1762LW 1762LX 178DHL 179EPT 179EPU Product Description: 25+ TTL PLUS VPAK 20000CPM BWV Catalog Number: 8065830077 UDI-DI code: 380658300777 Lot Numbers: 1754RH 1754RJ 1754RK 1754RL 1754UW 1754UX 175M4H 175M4J 175M4K 175M4L 1762LH 1762LK 1762LJ 176WUU 176WUV 1776DA 177FEA 177FEC 177TV9 177TVA 1782JW 1782JX 178DF7 178DF8 178DF9 178DFA 178RTC 179EPA 179EPC 179U0V 179U0W 179U0Y 17A4XX 17A4XW 17AVN2 17C7E6 17C7E4 17C7E2 17C7E3 17C7E5", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "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.", "Status": "recorded" } } ] } ] }