Catalog Number 8065977763 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/23/2020 |
Event Type
malfunction
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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported there were three instances of intraocular lenses (iols) appearing to have a hole, chip, or tear in them.The customer is confident it is being caused by the cartridge as the cartridges appear to be 'irregular' on the inside.There is no reported patient impact.Additional information was requested.There are three reports associated with this as two lot numbers were provided and one is unknown.
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Manufacturer Narrative
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Additional information provided in h.3., h.6., and h.10.The product was not returned.All product and batch history records are quality reviewed prior to product release.The associated lens, handpiece and viscoelastic information was not provided.It is unknown if a qualified combination was used.The root cause cannot be determined.The product was not returned to evaluate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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