The device with the iol was returned.The plunger lock and lens stop have been removed.Viscoelastic is dried in the device.The plunger is oriented correctly.The plunger has been retracted into the loading area.The lens is located just inside the nozzle entry area.The leading and trailing haptics are in acceptable positions.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic used was not provided.It is unknown if a qualified viscoelastic product was used in the device.The root cause could not be determined for 'blocked in injector, capsular rupture".The device was returned with lens advanced to just inside the nozzle entry area.The plunger was retracted into the loading area.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The root cause of the capsular rupture cannot be determined.Lens delivery and removal from the eye cannot be confirmed based on the position of the iol in the device when returned.It is possible that the lens has been replaced into the device for return.(b)(4).
|