Model Number TOP27G22 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date of event: unknown, not provided.If implanted, give date: not applicable.If explanted, give date: not applicable.(b)(6).Device manufacture date: unknown.All pertinent information available to abbott medical optics has been submitted.
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Event Description
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It was reported that a customer ordered top needle angle 27g22 and the customer received top27g22, lot-5k08m.However, the label on the tyvek pack of the inside product was top needle straight 27g26(top27g26), lot-5l01m.No patient injury reported.No patient contact reported.No additional information was provided.
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Manufacturer Narrative
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Corrected data: upon further review of this file it was determined that the initial mdr was filed in error.The reported device is not same or similar to a product distributed/ sold in the united states.Device evaluation: the returned product was received at the manufacturer.There were no manufacturing errors identified on the returned product.Therefore, no product deficiency was identified.This may have been a user error issue.Additionally, there were no discrepancies or defects found during the manufacturing record review (mrr).The documentation shows that the production order was manufactured according to specifications.Based on the investigation results there is no indication of product quality deficiency.All pertinent information available to the manufacturer has been submitted.
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Search Alerts/Recalls
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