Article 33(1) of REACH indicates a “duty to communicate information on substances in articles” to allow for their safe use. This statement specifically refers to substances defined in Article 57 as “Substances of Very High Concern” (SVHCs) and these substances are identified on the SVHC Candidate List per Article 59.
The table below indicates product categories that may contain substance(s) of very high concern (SVHCs) above a threshold of 0.1 percent w/w. Alcon products contained within these categories are classified as “articles with no intentional release.” The continued use of the medical devices listed below is safe and compliant with regulations. The following information is based on our current knowledge and current supplier information.
For further information regarding the safe use of these designated products, please contact Alcon's Supply Chain Environmental Management team.
| PRODUCT CATEGORIES - BIS (2-ETHYLHEXYL) PHTHALATE (DEHP) - CAS # 117-81-7 | ||
|---|---|---|
| ACCURUS® EQUIPMENT | CONSTELLATION® VIT PROBE | OVERLAY - PHACO ACCESSORIES |
| ACCURUS® INSTRUMENT ACCESSORIES | DUST COVERS | PHACO ACCESSORIES |
| ACCURUS® PAKS | GFI® TUBING SET - VITREOUS DISPOSABLES | PHOTOCOAG LASER ACCESSORIES |
| ACCURUS® TURBOSONIC PAKS | GFX INFUSION LINE WITH FILTER | PUREPOINT® LASER |
| BIPOLAR PRODUCTS | INFINITI® VISION SYSTEM | STANDALONE ACCURUS® PROBES |
| CO-AXIAL ANT VIT INFUSION SLEEVE | INFINITI® ANT VIT ACCESSORIES | STANDALONE PROBELESS PAKS |
| COMBINED PROCEDURE PAKS | INFINITI® PAKS | STD TURBOSONICS® TIPS |
| CONSTELLATION® AUTO GAS FILLER | INFUSION - VITREOUS DISPOSABLES | TOTAL PLUS PAKS |
| CONSTELLATION® AUXILIARY ILLUMINATOR | LASERS PHOTOCOAGULATOR | ULTRASOUND ACCESSORIES |
| CONSTELLATION® BASE UNIT | LAUREATE® VISION SYSTEM | UNIVERSAL - UPGRADES |
| CONSTELLATION® PAKS | LAUREATE® PAKS | UNIVERSAL PAKS |
| CONSTELLATION® PHACO PAKS | LEGACY® PAKS | VGFI® - VITREOUS DISPOSABLES |
| CONSTELLATION® TRAY ARM KIT | MVS®/AUMVS DISPOSABLES | VIT DISPOSALBES - TUBING SET |
| CONSTELLATION® VISION SYSTEM | OCUSCAN® | VIT RET ACCESS INFINITECH |
