Catalog Number 14132 |
Device Problems
Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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 doctor reported that needle shot off the syringe during surgery.The doctor felt that syringe and needle were loose when using the product.The product was replaced and procedure completed with no patient harm.The sample is not available for return.
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Manufacturer Narrative
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(b)(4).
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Event Description
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New information from customer indicates that the intraocular lens positioning failed due to posterior capsule damage.The patient is complaining that he is dissatisfied with the different appearance of other eye.The doctor indicated that the connection between the syringe and blunt needle felt loose and was tightened.If the patient continues having issues, the patient will be taken outside the facility for further evaluation.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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The postoperative visual acuity has not improved as expected.
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Manufacturer Narrative
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The finished good lot specific to this event is not known; therefore, lot history and device history record review was not possible.The customer reported that the needle shot and came off like a rocket during surgery.There was no patient harm.The customer¿s complaint could not be investigated as the customer did not retain a sample for this complaint report.Without a sample, visual inspection could not be conducted.The supplier conducted a shape test and the result met their quality standard and no other anomalies were observed.They also performed a functionality test on 10 reference samples; no reported event occurred.The supplier was unable to identify a root cause.This is a complaint against a japan component that is import for export.The file will be processed for closure and opened at a later date if a sample is received or additional information is provided by the supplier.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is impossible to isolate the root cause and it is unknown.It has been determined that no action will be taken at this time as a sample was not returned.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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