Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a.Healon is not an implantable device.If explanted; give date: n/a.Healon is not an implantable device, therefore, not explanted.Phone: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
|
Section d10 - device available for evaluation? yes.Section d10 - date returned to manufacturer: 21st january 2021.Section h3 - device evaluated by manufacturer? yes.Visual inspection and the stereomicroscope inspection of the complaint sample, the customer¿s narrative, and the reported device problem code of dc-foreign material - loose, the complaint is confirmed.The material appears to be a gray coring particle which is formed when the healon cylinder is activated.Manufacturing record evaluation: a device history record (dhr) for healon gv pro, lot# uh31302 was performed.No deviation related to the complaint is reported in the manufacturing record.A review of records related to the device including labeling, complaint trending, and risk documentation was performed.The review of the device history record (dhr) for healon gv pro, lot# uh31302 showed that there were no issues or non-conformities.The healon gv pro met all specifications prior to being released.Based on the investigation results, no corrective action has been issued a review of the records related to healon gv pro that included labeling, manual, and risk documentation reviews was performed.Labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.Conclusion: although, the complaint was confirmed, the presence of a gray rubber coring particle upon expelling healon solution is a known issue and is addressed in the healon pro family products¿ risk assessments.However, as there is no indication of an upward trend in the number of complaints with this type of issue.Additionally, the directions for use(dfu) has the following statement ¿express a small amount of healon5 pro ovd over from the syringe prior to use and carefully examine it during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured.".Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.No further investigation is required at this time.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
|