Model Number P-50 PL |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/09/2015 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: no data regarding product identity including serial number or lot number was received therefore the device history record could not be reviewed.No sample was returned and the device remains implanted.Root cause cannot be determined.No further information is expected.The manufacturer internal reference number is: (b)(4).
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Event Description
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Following a glaucoma filtration implant surgery a surgeon reported the device gradually began to push outward against the scleral flap ultimately going through and exposing the external plate.No medical intervention was performed.The device remains implanted.
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Manufacturer Narrative
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Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Event Description
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In a follow up a surgeon reported no change in intraocular pressure (iop) pre and post shunt implantation.The device was explanted due to risk of infection.
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Manufacturer Narrative
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Evaluation summary: customer reported that after a glaucoma shunt implant surgery the shunt gradually began to push outward against the scleral flap.No data regarding product identity was received i.E.No lot or serial number were indicated for the event; therefore, the device history record (dhr) could not be reviewed.Product was returned for investigation and was found to be proper during visual inspection.Furthermore, the spur hight was measured and found to meet specification.Therefore, there is no indication for a manufacturing related factors that could cause such an event.The root cause could not be conclusively determined and does not seem to be device related.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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