title: [Role of conditioning medium cytotoxicity. An example with an intraocular lens preloaded in injector].
abstract: BACKGROUND
  Following material vigilance cases encountered with the hydrophilic acrylic intraocular lens, ACR6D SE preloaded in the Premier shooter, we studied the cytotoxicity of the intraocular lens and its conditioning to identify the cytotoxic element. We proposed medical device modification to improve its biocompatibility.
  
  
  METHODS
  Biocompatibility-cytotoxicity assays were carried out according to ISO 10993-5 recommendations. Tests were performed on the SRA 01/04 human lens epithelial cell line. Neutral red, Hoechst 33342, and YO-PRO-1 fluorescent probes were used to assess membrane integrity, total DNA, and membrane fluidity, respectively. Materials samples were prepared in culture medium according to the ISO 10993-5 elution procedure. Pure saline solutions and conditioning liquids were tested directly on cells.
  
  
  RESULTS
  The intraocular lens and injector were not cytotoxic. Conditioning liquids induced membrane fluidity perturbation characteristic of apoptosis. Tests performed on new versions of the medical device identified a better adapted conditioning liquid.
  
  
  CONCLUSIONS
  The results suggest that the cytotoxicity of the conditioning liquid could explain the postoperative complication rate. When we changed the conditioning liquid with sterile irrigating solution (i.e., rich divalent cation marine solution), we eliminated cellular stress. Fluorescent probes are well adapted to assess medical device biocompatibility-cytotoxicity.
authors.affiliation: Laboratoire de Toxicologie, Faculté de Pharmacie, Université Paris 5, France.
authors.forename: A
authors.initials: A
authors.lastname: Staropoli
authors.forename: C
authors.initials: C
authors.lastname: Baudouin
authors.forename: M
authors.initials: M
authors.lastname: Dutot
authors.forename: G
authors.initials: G
authors.lastname: Sultan
authors.forename: J-M
authors.initials: JM
authors.lastname: Warnet
authors.forename: P
authors.initials: P
authors.lastname: Rat
mesh_terms: D001672:Biocompatible Materials; D002478:Cells, Cultured; D006801:Humans; D007267:Injections / Q000295:instrumentation; D007910:Lenses, Intraocular; D012996:Solutions / Q000009:adverse effects*; D018675:Toxicity Tests
chemical_list: D001672:Biocompatible Materials; D012996:Solutions