Model Number CATALYS-U |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Eye / Vision Problem (4471)
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Event Date 01/19/2024 |
Event Type
Injury
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Event Description
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It was reported that the surgery had poor wound closure from the primary incision and the surgeon used visco to seal the wound.No additional information was provided.
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Manufacturer Narrative
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Section a4 and a5: account did not have this information.Device evaluation: an application support manager (asm) was at the site and advised the doctor to change the anterior cut angle of the wound to help with closure.Asm updated the anterior side cut angle from 70 to 90.Conclusion: as a result of the investigation 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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Additional information: section d4 unique identifier (udi) number: in the initial report the udi number was inadvertently omitted and the number is - (b)(4).Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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