ISO 11979-4:2008

Overview

ISO 11979-4:2008 specifies labelling and information requirements for intraocular lenses (IOLs) - ophthalmic implants used in cataract and refractive surgery. The standard defines the minimum information to appear on primary and protective packaging, the required package leaflet (instructions), and optional self-adhesive labels. Its purpose is to harmonize global IOL labelling practices so surgeons and healthcare providers receive correct, sufficient technical and safety information.

Key topics and requirements

• Scope: labelling for IOLs and information to be provided within or on packaging.
• Minimum information required on packaging (primary and/or storage/protective):
  • Manufacturer name (or trade name) and address, country of manufacture
  • Commercial name/model designation
  • Lot code or serial number
  • Sterility statement (e.g., “STERILE”) and sterilization method
  • “Do not resterilize” and “Single use” statements where applicable
  • Expiry date (YYYY MM)
  • Dioptric power (units m^-1 or D)
  • Total diameter and optic/body dimensions (mm), optionally shown in a drawing
  • Lens configuration drawing and intended implantation location (anterior chamber, posterior chamber, in-the-bag, etc.)
  • Information to aid the surgeon in calculating implant power and any specific storage conditions
• Package leaflet (instructions for use) must include:
  • Detailed lens description and materials
  • Sterilization method, storage/transport conditions
  • Instructions for removal from primary package and use
  • Indications, contraindications, possible complications
  • Warnings about compromised sterile packaging and non-reuse
  • For multifocal IOLs: clinical summary and modulation transfer function (MTF) curve per ISO 11979-9
  • For phakic IOLs: recommended post-implantation evaluations and any indication restrictions
• Self-adhesive label (if provided) minimal content: manufacturer name, product/model, lot, dioptric power, additional power (multifocal), total diameter, body diameter.
• Symbols may replace text following ISO 15223-1 or EN 980.

Applications and users

• Primary users: IOL manufacturers, regulatory and quality teams preparing device labelling and IFU.
• Secondary users: Packaging engineers, clinical trial sponsors, ophthalmic surgeons, distributors, and notified bodies/regulators.
• Practical uses: ensure regulatory compliance, improve surgical safety and traceability, support product information for clinical use and post-market surveillance.

Related standards

• ISO 11979-1 (vocabulary) and ISO 11979-9 (multifocal IOLs)
• ISO 15223-1 (medical device symbols)
• EN 980 (labelling symbols)
• EN 1041 (manufacturer information for medical devices)
• ISO 11607‑1 / ISO 11607‑2 (sterile barrier and packaging validation)

Keywords: ISO 11979-4, intraocular lenses, IOL labelling, ophthalmic implants, medical device labelling, packaging information, sterility, instructions for use.