Model Number SA60WF |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing device history records (dhr) were reviewed and shows that the product met specification prior to release and shows no other complaints in this lot.A product sample was not returned therefore, the reported event cannot be confirmed.The root cause of the reported event cannot be determined; however, should additional reportable information become available, a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.(b)(4).
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Event Description
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A facility representative reported an intraocular lens that was "curled in shooter".There was contact with the patient but the procedure was completed with no patient harm reported.Additional information requested.
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Manufacturer Narrative
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Corrected and additional information was provided in b.2, b.5, d.10, and h.10.No supplemental report will be required as the additional information provided indicated that there was no patient contact.Had this information been received prior to submission of the initial medical device report the reported event would not have been reportable.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received states that there was no patient contact.
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Search Alerts/Recalls
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