Model Number PCB00 |
Device Problems
Difficult or Delayed Positioning (1157); Torn Material (3024)
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Patient Problem
No Information (3190)
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Event Date 05/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.(b)(6).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 during the injection of a pcb00 intraocular lens (iol), there was resistance during use and when injected the iol was ripped on the optic edge.No additional information provided.
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Manufacturer Narrative
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Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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