{
  "code": "LPL",
  "deviceName": "Lenses, Soft Contact, Daily Wear",
  "deviceClass": "II",
  "regulationNumber": "886.5925",
  "panel": "Ophthalmic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 486,
    "last12Months": 12
  },
  "adverseEvents": {
    "total": 681,
    "last12Months": 132
  },
  "reviewDays": {
    "median": 84,
    "sampleSize": 486
  },
  "recalls": {
    "total": 70,
    "recent": [
      {
        "resNumber": "Z-0326-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Alcon Research, LLC",
        "firmAsPublished": "Alcon Research LLC",
        "reason": "Potential for a weak seal in some units resulting in compromise in sterility.",
        "initiated": "2025-09-30"
      },
      {
        "resNumber": "Z-2163-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Johnson & Johnson Vision Care, Inc.",
        "firmAsPublished": "Johnson & Johnson Vision Care, Inc.",
        "reason": "Due to defects (bubbles/voids) identified during standard finished goods testing",
        "initiated": "2025-06-12"
      },
      {
        "resNumber": "Z-3313-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Alcon Research, LLC",
        "firmAsPublished": "Alcon Research LLC",
        "reason": "Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.",
        "initiated": "2024-08-08"
      },
      {
        "resNumber": "Z-1282-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "CooperVision, Inc.",
        "firmAsPublished": "CooperVision, Inc.",
        "reason": "The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.",
        "initiated": "2023-02-14"
      },
      {
        "resNumber": "Z-1014-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "CooperVision, Inc.",
        "firmAsPublished": "CooperVision, Inc.",
        "reason": "Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.",
        "initiated": "2022-12-27"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260507",
      "deviceName": "Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus",
      "applicant": "INTEROJO, Inc.",
      "company": "INTEROJO, Inc.",
      "decisionDate": "2026-05-29",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K253352",
      "deviceName": "Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses",
      "applicant": "Pegavision Corporation",
      "company": "Pegavision Corporation",
      "decisionDate": "2026-05-21",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K261299",
      "deviceName": "Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses",
      "applicant": "Pegavision Corporation",
      "company": "Pegavision Corporation",
      "decisionDate": "2026-05-19",
      "dateReceived": "2026-04-20"
    },
    {
      "kNumber": "K253885",
      "deviceName": "PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES",
      "applicant": "GEO MEDICAL CO., LTD.",
      "company": "GEO MEDICAL CO., LTD.",
      "decisionDate": "2026-04-29",
      "dateReceived": "2025-12-04"
    },
    {
      "kNumber": "K254269",
      "deviceName": "Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens",
      "applicant": "St. shine Optical Co., Ltd.",
      "company": "St. shine Optical Co., Ltd.",
      "decisionDate": "2026-03-19",
      "dateReceived": "2025-12-30"
    },
    {
      "kNumber": "K252385",
      "deviceName": "Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses",
      "applicant": "Pegavision Corporation",
      "company": "Pegavision Corporation",
      "decisionDate": "2026-03-13",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K254052",
      "deviceName": "DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal",
      "applicant": "Alcon Laboratories, Inc.",
      "company": "Alcon Laboratories, Inc.",
      "decisionDate": "2026-02-13",
      "dateReceived": "2025-12-17"
    },
    {
      "kNumber": "K251683",
      "deviceName": "Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)",
      "applicant": "Bruno Vision Care, LLC",
      "company": "Bruno Vision Care, LLC",
      "decisionDate": "2025-12-23",
      "dateReceived": "2025-05-30"
    },
    {
      "kNumber": "K250364",
      "deviceName": "Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens",
      "applicant": "St. shine Optical Co., Ltd.",
      "company": "St. shine Optical Co., Ltd.",
      "decisionDate": "2025-10-07",
      "dateReceived": "2025-02-10"
    },
    {
      "kNumber": "K244009",
      "deviceName": "Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)",
      "applicant": "Yung Sheng Optical Co., Ltd.",
      "company": "Yung Sheng Optical Co., Ltd.",
      "decisionDate": "2025-09-25",
      "dateReceived": "2024-12-26"
    }
  ],
  "topApplicants": [
    {
      "name": "CooperVision, Inc.",
      "count": 37
    },
    {
      "name": "Alcon Laboratories, Inc.",
      "count": 22
    },
    {
      "name": "Ciba Vision Corporation",
      "count": 14
    },
    {
      "name": "Pegavision Corporation",
      "count": 14
    },
    {
      "name": "Unilens Corp., USA",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "CooperVision, Inc.",
      "count": 37,
      "spellings": 1
    },
    {
      "name": "Alcon Laboratories, Inc.",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "Bausch and Lomb, Incorporated",
      "count": 20,
      "spellings": 4
    },
    {
      "name": "Ciba Vision Corporation",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Pegavision Corporation",
      "count": 14,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 31,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 39,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 14,
        "expectedLow": 7.3038044929922075,
        "expectedHigh": 38.712958827007256,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 14,
        "expectedLow": 4.856153385165825,
        "expectedHigh": 30.663480492066256,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 10,
        "expectedLow": 4.19753507655151,
        "expectedHigh": 33.30972688171249,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 18,
        "expectedLow": 0,
        "expectedHigh": 33.19920404382214,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 29,
        "expectedLow": 0.21481873602715462,
        "expectedHigh": 31.702874767030362,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 19,
        "expectedLow": 3.658431391863436,
        "expectedHigh": 37.78621131101676,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 22,
        "expectedLow": 5.9054438507945655,
        "expectedHigh": 57.49269295814071,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 12,
        "expectedLow": 2.007187003092701,
        "expectedHigh": 41.26094713251047,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 19,
        "expectedLow": 0,
        "expectedHigh": 41.91542583514003,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 19,
        "expectedLow": 1.666865711643961,
        "expectedHigh": 37.42709079931669,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 16,
        "expectedLow": 5.691670355594849,
        "expectedHigh": 28.73180695509502,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 18,
        "expectedLow": 5.851760191080991,
        "expectedHigh": 31.469179524765437,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 21,
        "expectedLow": 6.432656428294415,
        "expectedHigh": 36.05557249344748,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 14,
        "expectedLow": 5.480565184833676,
        "expectedHigh": 30.405383405175655,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 20,
        "expectedLow": 4.212318063307906,
        "expectedHigh": 32.326729451839554,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LPL (Lenses, Soft Contact, Daily Wear) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0326-2026). Clearances are running 74% slower — a median 146 days over the last 12 months against 84 days all-time (elapsed calendar days, not FDA review days) (LPL:review_time:12m). The code is crowded, scoring 74 of 100 — 138 companies hold a clearance here and 12 arrived in the last 12 months (LPL:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0326-2026"
        ],
        "severity": 75
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 74% slower — a median 146 days over the last 12 months against 84 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "LPL:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 74 of 100 — 138 companies hold a clearance here and 12 arrived in the last 12 months",
        "recordIds": [
          "LPL: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%3ALPL"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALPL"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALPL"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALPL"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALPL"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALPL"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALPL"
    }
  ],
  "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": "2026-08-11T13:51:45.740Z"
}