Z-2110-2025.jsonld
type: Dataset
name: Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
description: FDA recall Z-2110-2025 — Alcon Research LLC is recalling Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. 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/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
  manufacturer: Alcon Research LLC
claims: enforcement-record
claims: FDA classified recall Z-2110-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2110-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2110-2025
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Alcon Research LLC
      status: recorded
  item list element: 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
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-04-28
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Lot Code: Many - See 'Attachment 1 - Affected Product List' Catalog Number / Lot Number / Custom Pak Description/ UDI-DI code: 0094-77 17C3H9 J-CAT PAK - CVS KENRITSU NINOHE HP 380655137888 10366-13 17CY90 AUS-CATARACT BRISBANE WATERS 380655161951 10924-15 176JX0 25G VIT 25G OPTICARE EYE HLTH CTR 380651690714 11201-11 17A18R AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11201-11 17A1AW AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11220-27 176NYN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772HN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772L9 VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 177URH VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179TKU VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CF2K VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMJJ VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMMW VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CLCN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179Y3T VITRECTOMY 25G NORTHSIDE HOSP 380655178492 1137-65 17A46H CATARACT FRENCH HOSP CORP 380653436938 1137-65 17CXY9 CATARACT FRENCH HOSP CORP 380653436938 12568-09 178PTE 23G CONSTELLATION NORTHERN MICH SPPLY AL 380653414561 12568-09 17CK02 23G CONSTELLATION NORTHERN MICH SPPLY AL 380653414561 12641-14 178KD6 AUS-25GA VIT RET BRISBANE WATERS 380655181935 12852-16 179N1E AUS-23GA 10K COMBINED VR PAK NEW CHILDRE 380655158425 13110-11 17AKR3 23GA CVS RETINA TPP V A HOSP HOUSTON 380655177549 13501-08 177DMP 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 178423 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 178N3H 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 178UD9 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 17AHCE 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 17AX1V 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 17CCAH 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13502-10 17703Y 25+G 20…
      status: recorded
  item list element: 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

enforcement-record
type: Claim
name: FDA recall Z-2110-2025: Alcon Research LLC is recalling Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
text: The FDA logged enforcement record Z-2110-2025: Alcon Research LLC is voluntarily recalling Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. 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' Catalog Number / Lot Number / Custom Pak Description/ UDI-DI code: 0094-77 17C3H9 J-CAT PAK - CVS KENRITSU NINOHE HP 380655137888 10366-13 17CY90 AUS-CATARACT BRISBANE WATERS 380655161951 10924-15 176JX0 25G VIT 25G OPTICARE EYE HLTH CTR 380651690714 11201-11 17A18R AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11201-11 17A1AW AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11220-27 176NYN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772HN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772L9 VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 177URH VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179TKU VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CF2K VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMJJ VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMMW VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CLCN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179Y3T VITRECTOMY 25…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
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.

FDA classified recall Z-2110-2025 as Class II
type: Claim
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.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
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.

What an FDA recall is — and is NOT
type: Claim
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.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
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.