Alcon is conducting an ongoing investigation of reports of post-operative inflammation that were reported in cataract surgery patients implanted with restor and restor toric family of iols in (b)(6) since mid-january 2015.In the interest of patient safety, all restor and restor toric iols were voluntarily recalled from the (b)(6) market on 15-apr-2015 and surgeons in (b)(6) were advised not to implant the restor and restor toric family of iols.Following this recall, an increase in the number of cases of post-operative inflammation were reported for acrysof® iq toric iol models sn6at6, sn6at7, sn6at8 and sn6at9.Therefore, on september 29, 2015 the voluntary recall was expanded to include these additional lens models.Evaluation summary: the customer indicated the use of an approved cartridge with an unspecified handpiece.The cartridge and handpiece product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The customer indicated the use of a qualified viscoelastic.
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