Model Number 690697 |
Device Problems
Accessory Incompatible (1004); Increase in Suction (1604)
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Patient Problems
Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
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Event Date 09/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Patient code of (b)(4) is provided for incision enlargement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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During a cataract procedure, a capsular rupture occurred on the right operative eye resulting in a vitrectomy procedure and an incision enlargement.A description from the surgery center indicated during the surgery, the phaco handpiece had slow aspiration at first and suddenly the aspiration became too aggressive.The procedure was completed and the intraocular lens (iol) was implanted in the sulcus with optic capture.The patient outcome is expected good.
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Manufacturer Narrative
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Device available for evaluation? yes.Returned to manufacturer on: 12/06/2018.Device returned to manufacturer? yes.Device evaluation: the device was returned to the manufacturer.The handpiece was evaluated.No abnormal conditions were observed during the testing of the device.The reported issue was not confirmed.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.The risk management files and trending were reviewed.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.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.No labeling change is required.The review of the device history record (dhr) for ellips whitestar phaco handpiece showed that there were no related issues or related non-conformities.Manufacturing has been ruled out as a potential cause for the reported issue.No conclusive evidence identified for reported issue.The handpiece is working within j&j specifications.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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