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Model Number TG85ML |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted; give date: n/a (not applicable).The healon gv pro is not an implantable device.If explanted; give date: n/a (not applicable).The healon gv pro is not an implantable device.The device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, no definitive response has been received.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 a customer used healon gv pro and noticed white specs in the patient's eye.The white specs seemed to come out during irrigation/aspiration (i/a).The lens was implanted fine.As of now, no known visual issues.No known patient injury.No other information was provided.
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Manufacturer Narrative
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Additional information: products were not returned however two images of the alleged particle were provided.Analysis of the images did not reveal any relevant information regarding the complaint event.The non-conformance /deviation within the device history record is unrelated to the issue reported by the customer.As a result there is no indication of a product quality deficiency.All devices meet material, assembly, and performance specifications at the time of product release.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Section d9: device available for evaluation? yes.Returned to manufacturer on: aug.25, 2022.Section h3: device evaluated manufacturer? yes.Device evaluation: complaint sample consisted of a glass cylinder and a plunger rod attached.No healon solution remaining.As no material finds were found within the complaint sample, no instrumental analysis for identification of any foreign material was carried out.The material finds observed by the customer were not returned for analysis.Based upon the visual inspection of the returned product, there is no indication that the customer's observation is due to an issue with the healon gv pro product.Therefore, the customer's report is not confirmed by this investigation.As this investigation has not observed the foreign material reported by the customer, then no product defect (material finds in the solution) can be confirmed.Based upon the visual inspection of the returned product, there is no indication that the customer's observation is due to an issue with the healon gv pro product.Therefore, the customer's report is not confirmed by this investigation and no product defect has been observed.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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