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Model Number NGP680301 |
Device Problems
Use of Device Problem (1670); Suction Problem (2170); Application Network Problem (2879)
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Patient Problems
Corneal Abrasion (1789); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/14/2023 |
Event Type
Injury
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Event Description
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It was reported that customer found nuclear fragments remained in the anterior chamber during the post exams.Surgeon perceived that the vacuum performance during irrigation aspiration and phaco mode was bit low.The issue had occurred in three procedures since after the machine was checked on (b)(6) 2023.Reportedly transconjunctival single plane scleracorneal incision method was used with 2.55 mm incision size.There was no incision widened.Irrigation, suction, and removal with irrigation aspiration is planned for end of (b)(6) 2023.Patient was prescribed with medication (levofloxacin, sanbetason).The patient outcome was reported as good visual acuity with no problems.The pack was reused for the patient.Additional information was received, and it was learnt that on (b)(6) 2023 there was removal of residual nuclear fragments performed using ophthalmic anesthesia.Surgeon aspirated by using a bi-manual irrigation aspiration (ia) while shattering nuclear fragments with the tip.Nuclear fragments were aspirated without problems.There was descemet's fold that seemed to be caused by an effect of the bi-manual ia operation.As a result, visual acuity decreased from 0.9 to 0.6, but according to the doctor, it is likely to recover gradually.This event will capture information for 1 of 3 patients.Other reports are being submitted for other patients.No further information was provided.
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Manufacturer Narrative
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Additional narrative information: telephone number: (b)(6).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: a review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews was performed.Equipment 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: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Corrected data: at the time of initial filing following health effect impact code and clinical code was inadvertently missed, hence this is being added.Section h6: health effect-impact code ¿ 4625 for secondary surgical intervention: surgical intervention section h6: health effect-clinical code ¿ 1789 for striae in descemet's: corneal striae.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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