{ "code": "HQC", "deviceName": "Unit, Phacofragmentation", "deviceClass": "II", "regulationNumber": "886.4670", "panel": "Ophthalmic", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 316, "last12Months": 3 }, "adverseEvents": { "total": 5711, "last12Months": 1190 }, "reviewDays": { "median": 88, "sampleSize": 316 }, "recalls": { "total": 74, "recent": [ { "resNumber": "Z-0305-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Alcon Research, LLC", "firmAsPublished": "Alcon Research LLC", "reason": "Due to incomplete seals in the pouch which provide the sterile barrier.", "initiated": "2025-08-05" }, { "resNumber": "Z-2109-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Alcon Research, LLC", "firmAsPublished": "Alcon Research LLC", "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.", "initiated": "2025-04-28" }, { "resNumber": "Z-2646-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Alcon Research, LLC", "firmAsPublished": "Alcon Research LLC", "reason": "Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.", "initiated": "2024-07-15" }, { "resNumber": "Z-2647-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Alcon Research, LLC", "firmAsPublished": "Alcon Research LLC", "reason": "Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.", "initiated": "2024-07-15" }, { "resNumber": "Z-2671-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Alcon Research, LLC", "firmAsPublished": "Alcon Research LLC", "reason": "Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.", "initiated": "2024-07-15" } ] }, "recentClearances": [ { "kNumber": "K261264", "deviceName": "Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+", "applicant": "Bausch and Lomb", "company": "Bausch and Lomb, Incorporated", "decisionDate": "2026-05-15", "dateReceived": "2026-04-16" }, { "kNumber": "K252052", "deviceName": "Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)", "applicant": "Bausch and Lomb, Incorporated", "company": "Bausch and Lomb, Incorporated", "decisionDate": "2026-03-25", "dateReceived": "2025-07-01" }, { "kNumber": "K250501", "deviceName": "System Sophi", "applicant": "This AG", "company": "This AG", "decisionDate": "2025-11-14", "dateReceived": "2025-02-20" }, { "kNumber": "K243395", "deviceName": "MICOR 700 with Auto I/A", "applicant": "Carl Zeiss Meditec Cataract Technology, Inc.", "company": "Carl Zeiss Meditec Cataract Technology, Inc.", "decisionDate": "2025-08-08", "dateReceived": "2024-10-31" }, { "kNumber": "K242801", "deviceName": "MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)", "applicant": "Carl Zeiss Meditec Cataract Technology, Inc.", "company": "Carl Zeiss Meditec Cataract Technology, Inc.", "decisionDate": "2025-06-11", "dateReceived": "2024-09-17" }, { "kNumber": "K240169", "deviceName": "Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)", "applicant": "Bausch and Lomb, Incorporated", "company": "Bausch and Lomb, Incorporated", "decisionDate": "2024-07-26", "dateReceived": "2024-01-22" }, { "kNumber": "K233398", "deviceName": "Faros Surgical System", "applicant": "Oertli Instrumente AG", "company": "Oertli Instrumente AG", "decisionDate": "2024-06-27", "dateReceived": "2023-10-03" }, { "kNumber": "K233876", "deviceName": "UNITY VCS (8065000296); UNITY CS (8065000297)", "applicant": "Alcon Laboratories, Inc.", "company": "Alcon Laboratories, Inc.", "decisionDate": "2024-06-21", "dateReceived": "2023-12-07" }, { "kNumber": "K232084", "deviceName": "Stellaris Elite vision enhancement system", "applicant": "Bausch and Lomb", "company": "Bausch and Lomb, Incorporated", "decisionDate": "2024-02-26", "dateReceived": "2023-07-13" }, { "kNumber": "K233902", "deviceName": "Centurion™ Vision System (Active Sentry™) (8065753057)", "applicant": "Alcon Laboratories, Inc.", "company": "Alcon Laboratories, Inc.", "decisionDate": "2024-01-10", "dateReceived": "2023-12-11" } ], "topApplicants": [ { "name": "Storz Instrument Co.", "count": 17 }, { "name": "Chiron Vision Corp.", "count": 15 }, { "name": "CooperVision, Inc.", "count": 15 }, { "name": "Site Microsurgical Systems, Inc.", "count": 14 }, { "name": "Abbott Medical Optics, Inc.", "count": 9 } ], "topCompanies": [ { "name": "Storz Instrument Co.", "count": 17, "spellings": 1 }, { "name": "Bausch and Lomb, Incorporated", "count": 15, "spellings": 5 }, { "name": "Chiron Vision Corp.", "count": 15, "spellings": 1 }, { "name": "CooperVision, Inc.", "count": 15, "spellings": 1 }, { "name": "Site Microsurgical Systems, Inc.", "count": 14, "spellings": 1 } ], "newEntrants": [ { "name": "This AG", "since": "2025-11-14", "kNumber": "K250501" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 158, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 115, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 138, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 195, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 144, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 145, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 133, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 111, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 164, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 152, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 133, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 345, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 160, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 154, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 134, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 176, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 177, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 194, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 169, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 187, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 177, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 101, "expectedLow": 46.29139977439258, "expectedHigh": 278.66815704254367, "isSufficient": true }, { "month": "2025-02-01", "observed": 122, "expectedLow": 18.62416534942341, "expectedHigh": 231.89808533774308, "isSufficient": true }, { "month": "2025-03-01", "observed": 81, "expectedLow": 23.504984434850996, "expectedHigh": 260.5294625447921, "isSufficient": true }, { "month": "2025-04-01", "observed": 209, "expectedLow": 68.98706007780284, "expectedHigh": 181.53941295762795, "isSufficient": true }, { "month": "2025-05-01", "observed": 164, "expectedLow": 78.45801202751264, "expectedHigh": 203.12724565598035, "isSufficient": true }, { "month": "2025-06-01", "observed": 122, "expectedLow": 87.11452472303753, "expectedHigh": 219.1517213243555, "isSufficient": true }, { "month": "2025-07-01", "observed": 171, "expectedLow": 120.15136823147195, "expectedHigh": 332.6055592235014, "isSufficient": true }, { "month": "2025-08-01", "observed": 159, "expectedLow": 74.31156786670212, "expectedHigh": 242.83587169946642, "isSufficient": true }, { "month": "2025-09-01", "observed": 161, "expectedLow": 78.90442510827909, "expectedHigh": 255.88714994472272, "isSufficient": true }, { "month": "2025-10-01", "observed": 154, "expectedLow": 79.99724181228305, "expectedHigh": 247.6329819650762, "isSufficient": true }, { "month": "2025-11-01", "observed": 138, "expectedLow": 69.460221378493, "expectedHigh": 221.32658159685607, "isSufficient": true }, { "month": "2025-12-01", "observed": 207, "expectedLow": 78.11087298667672, "expectedHigh": 238.7132886529679, "isSufficient": true }, { "month": "2026-01-01", "observed": 147, "expectedLow": 103.17277355066112, "expectedHigh": 293.79812968047736, "isSufficient": true }, { "month": "2026-02-01", "observed": 120, "expectedLow": 75.66729289370912, "expectedHigh": 235.29060293803204, "isSufficient": true }, { "month": "2026-03-01", "observed": 149, "expectedLow": 66.50177646844635, "expectedHigh": 249.0149234558664, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "HQC (Unit, Phacofragmentation) has two findings, most consequential first. 1 first-time filer in the last 12 months, This AG (K250501). The code is crowded, scoring 71 of 100 — 114 companies hold a clearance here and 3 arrived in the last 12 months (HQC:crowding).", "severity": 41, "factors": [ { "kind": "new_entrant", "detail": "1 first-time filer in the last 12 months, This AG", "recordIds": [ "K250501" ], "severity": 41 }, { "kind": "crowding", "detail": "the code is crowded, scoring 71 of 100 — 114 companies hold a clearance here and 3 arrived in the last 12 months", "recordIds": [ "HQC:crowding" ], "severity": 20 } ], "sourcesChecked": [ "predicate ancestry", "recalls", "adverse events", "new entrants", "review time", "crowding" ] }, "predicatePreview": { "edges": [], "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet." }, "sources": [ { "label": "classification", "url": "https://api.fda.gov/device/classification.json?search=product_code%3AHQC" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHQC" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHQC" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHQC" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHQC" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHQC" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHQC" } ], "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51, "exportDate": "2026-08-08" }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2, "exportDate": "2026-08-08" }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53, "exportDate": "2026-08-04" }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:49:57Z", "ingestRun": 73, "exportDate": "2026-08-11" }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52, "exportDate": "2026-08-08" }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10, "exportDate": "2026-08-08" } ], "retrievedAt": "2026-08-11T13:51:45.708Z" }