Article
„Dirty“ intraocular silicone oil
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Published: | May 30, 2012 |
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Background: Intraocular silicone oil impurities may cause intraocular inflammation, opacification of the optical media, retinal toxicity and emulsification.
Methods: Four patients who received 5000 cs medical grade silicone oil developed opacification of the intraocular silicone oil tamponade within few months after surgery. The medical charts and surgical notes of the respective patients were investigated in order to find out whether a common cause for the “dirty” oil could be determined.
Results: Chart review revealed that all patients that presented with “dirty” intraocular silicone oil had received silicone oil from the same production lot from a single manufacturer. All other patients that also had silicone oil intstillation from the same production lot were traced, informed and scheduled for silicone oil removal. Unused vials from the respective lot and samples obtained from patients during silicone oil removal were sent for mass spectrometry, the national regulatory authority (BfArM) and the manufacturer were informed.
Conclusion: Opacification of intraocular silicone oil could be traced down to a specific production batch of one manufacturer. Mass spectrometry and further chemical analysis are currently under way.