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