It was reported that during surgery, the doctor noticed a viscous material expel through the cartridge into the patient¿s eye during the intraocular lens (iol) implantation.As the iol is being pushed through the cartridge by the plunger of the inserter, the viscous material appears to be pushed by the bottom portion of the front haptic into the eye.The viscous substance then sticks to the iol.The doctor uses forceps to extract the viscous substance from the bottom surface of the iol and inside of the eye.This situation occurred during four surgical cases.All four events occurred the same day.No additional information was provided to abbott medical optics.Four (4) mdr¿s are being submitted.This report represents the first of four reports.
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Device available for evaluation: yes.Returned to manufacturer on: 08/15/2017.Device returned to manufacturer? yes.Device evaluation: sample was received along with dvds.Two 1mtec30 cartridges and a piece of paper with residue sample were received.The two cartridges were inspected under microscope magnification and viscoelastic residue was observed in the cartridge tubes.Cartridge damage was not observed in the samples received.The dvd¿s received were evaluated by the subject matter expert, and viscous material was observed in the cartridges used in the procedures recorded; therefore, the complaint was verified.Dye test was performed to both cartridges to monitor the coating presence.As a result, no dye presence was obtained.The complaint was verified, however, the cause of the complaint cannot be determined.The samples were submitted for analysis by fourier transform infrared (ftir) spectroscopy.Results: ftir analysis indicates the presence of sodium hyaluronate on the interior surface of one of the polypropylene cartridges.Ftir analysis indicates the possible presence of a modified vinyl polymer similar to polyvinylpyrrolidone on the interior surface of the second polypropylene cartridge.Ftir analysis indicates the residue on the bottom of the polypropylene specimen cup (residue sample) is consistent with a methacrylate species.Ftir analysis indicates the presence of kaolin (china clay) on the white portion of the carton surface.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search on complaints revealed that no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu provides the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is a potential product malfunction.An exception report (er394309) was opened to address this issue.These types of complaints will continue to be monitored.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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