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Model Number HEALON GV |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).Healon is not an implantable device.If explanted; give date: n/a (not applicable).Healon is not an implantable device.Phone number; (b)(6).The device is not returning for evaluation as it is discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that particles were found in the patient's eye post-cataract surgery.The account commented that no conclusions can be drawn at this point, but the product involved was the viscoelastic healon gv.Reportedly, the sample was discarded by the customer.No further information was provided.The same issue was reported for two patient, therefore two mdrs will be filed.This is the first of two.
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Manufacturer Narrative
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The healon gv syringe was not returned for inspection as it was discarded by the customer.However the cannula and 1 milliliter terumo plastic syringe, containing a colorless liquid (approx.0.2-0.4 ml) was returned for inspection.The liquid in the plastic syringe was inspected.There were no particles (no glass, hardened-silicone, blue rubber particles, materials associated with the primary packaging), fibers of any types or colors, air bubbles or other similar material finds in the colorless solution.Moreover, the customer's cannula was inspected.The inner surface of the cannula hub was free from fibers/particles and there was no foreign material on the outer surface of the cannula needle.Therefore, the customer¿s reported complaint was not verified.Visual inspection on retained products of healon gv lot# uc31132 was performed.35 samples were investigated.No visible defects were found on the package, cannula or solution.The solution was clear and colorless.All components were included in the product, without defects.The cannula was without damage.No visible defects on the product box.The printing on the carton and labels are correct.Product deficiency was not found on the retain samples.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
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Search Alerts/Recalls
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