Model Number PCB00 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Age at time of event or date of birth: unknown; however, year of birth is 1934.Date of event: unknown - the customer indicated that the date of event occurred from (b)(6) 2015 to (b)(6) 2015.Implant date: unknown.Explant date: not applicable; lens remains implanted at the time of submitting the mdr.(b)(6).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 the customer experienced some issues with different pcb00 on different dates from (b)(6) 2015 to (b)(6) 2015.The distal loop was opened in an advanced position at the moment of the insertion and slightly out of its cartridge, for this reason the surgeon is constrained to more complicated proceedings like re-loading the lens in another inserter.Two inserters were in lock position.All lenses have been implanted, but the surgeon was not happy to losing time about 4/5 minute delay in the procedure.There was no patient injury reported and no secondary surgery or medical intervention required.No further information was provided.Note:customer experienced issues with two preloaded insertion systems.Both medwatch reports will be filed separately for each serial number.This report is for serial number (b)(4).
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Manufacturer Narrative
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(b)(4).However upon further review of the complaint it was discovered the patient information entered is not applicable to this complaint and therefore does not apply.The patient¿s age and gender for this report is unknown.Additional information: the reported complaint cannot be confirmed due to the sample was not returned for evaluation.Therefore, no evaluation was performed.A review of the directions for use (dfu) was conducted.The dfu adequately provides instructions and precautions for the proper use and handling of the device.A manufacturing record review (mrr) was performed and shows product was manufactured according to specifications.All pertinent information available to abbott medical optics has been submitted.
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Manufacturer Narrative
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Correction data: correction to follow-up #1 report: age at time of event or date of birth: unknown; however, two (2) dates of birth were provided by the customer and it is unknown which date of birth applies to this reported complaint.Years of birth provided are 1934 and 1940.All pertinent information available to abbott medical optics has been submitted.
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Search Alerts/Recalls
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