Catalog Number 8065750180 |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).
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Event Description
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A customer reported that the unit freezes.Additional information has been requested, but none has been received to date.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Additional information received indicated the event took place prior to a cataract extraction with intraocular lens implant procedure.The system was re-booted and the case was initiated and completed as planned.There was no patient involvement.
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Manufacturer Narrative
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The system and handpiece were examined and the reported event was confirmed.The host was replaced as a preventive measure.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be established.(b)(4).
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Search Alerts/Recalls
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