A health care professional reported a faulty lens.Additional information has been requested and received stating that these lenses have been discovered faulty following the first lens bank audit since july 2022.The reporter no longer hold the physical lens or cartridge, identified lenses they had not used nor reported as faulty however, following an audit they have discovered they were not used due to a fault.
|
Additional information has been provided in b.3., b.5., h.3., h.6., and h.10.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the unspecified report of "faulty".It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the lens with preloaded delivery system, a company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.The manufacturer internal reference number is: (b)(4).
|