Date of event: unknown, information not provided.If implanted; give date: not applicable as the healon is not an implantable device.If explanted; give date: not applicable as the healon is not an implantable device.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported that a black monofilament hair/fiber came out of healon endocoat into the patient's anterior chamber (ac) as endocoat was injected at the beginning of the case to fill the ac.The syringe, endocoat, and cannula were all new, straight out of the sterile j&j packaging.The black fiber came out at the end of filling the ac (indicating that the black fiber had been deep within the endocoat in the syringe, not at the tip of the cannula).The black monofilament fiber was removed from the ac with intraocular forceps.It was reported patient is doing fine post operatively.No additional information was provided to johnson & johnson surgical vision.
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One opened unit of healon endocoat was received for evaluation on 12/17/2018.An assembled, partially used syringe was received, along with a swab containing a small, dark fiber (approx.2mm in length).Visual evaluation of the syringe could not identify any particulates/fibers within the remaining solution.Due to the returned opened condition and evidence of use, the source and origin of the fiber cannot be determined.The customer's reported event could not be confirmed.The manufacturing records were reviewed.There were no procedural nonconformities or interventions in the manufacturing of the lot that would indicate an elevated potential for fibers in the product solution.The product met the requirements for visible particulates for sub-assembly as well as the final product testing.There were no trends related to particulates for the raw material syringe, stopper, or cannula lots used in the manufacture of the product.There has been one similar complaints received for this lot.Complaint review indicates there have been no trends identified for particulates within solution for syringe products manufactured by this manufacturer.Review of components used to manufacture the lot, showed no complaint trends for the syringe, stopper, or cannula raw material lots.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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