Intraocular lenses

CRISTAVISC® c

VISCOELASTIC COHESIVE

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Designation Technical specifications
Eur. Ph. Injectable quality hyaluronic acid for Intraocular use,
from biofermentation origin		—
Each box contains1 syringe - 1 x 27G 7/8” canula - 1 leaflet -
8 traceability labels
Glass syringe, Pharmaceutical grade, Class I, latex free, prefilledAt 1 ml
NaHa concentration15,5 mg/g
Molecular weight of the hyaluronic acid in the final sterile product2.2 MDa (mean value)
Phosphate Buffer pH 7,2q.s. 1g
With natural antioxidantHyaluronic acid with mannitol
Isoosmolarity310 most (mean value)
pH6.8 – 7.6
Viscosity at 0,01s-1 shear rate170 Pa.s (170 000 cPoise) (mean value)
Apyrogen (free of endotoxins)< 0.5 EU/g
Sterile (gel by autoclave – second packaging, blister by ETO)SAL 10-6 (Sterility Assurance Level)
Proteins< 20 ppm
Storage2°C to 25°C for up to 36 months
Medical DeviceClass IIb
Biocompatible according toISO 10993 and ISO 15798
System of quality management in conformity toISO 13485

CRISTALENS INDUSTRIE
4 rue Louis de Broglie
22300 Lannion
France
Tél : +33 (0) 2 96 48 92 92
Fax : +33 (0) 2 96 48 97 87

CRISTALENS
Hyde park - Bât Westminster
12 allée Rosa Luxemburg
CS 50240 Eragny
95615 Cergy Pontoise Cedex
France
Tél : +33 (0) 1 34 32 30 50
Fax : +33 (0) 1 34 32 30 60

CRISTALENS
Carrer Roger de Llúria, 44
7è 4a
08009 Barcelona
España
Tél : +34 931 299 885
Fax : +34 933 969 168