Model Number SN6AT4 |
Device Problem
Power Problem (3010)
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Patient Problem
Blurred Vision (2137)
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Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: 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 an intraocular lens (iol) was exchanged following implant due to blurry vision and 'insufficient power'.Additional information was requested.
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Manufacturer Narrative
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The product was not returned for analysis.The root cause for the reported complaint could not be determined.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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