ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Catalog Number 8065741076 |
Device Problem
Incorrect Measurement (1383)
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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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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.(b)(4).
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Event Description
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A customer reported that there was an implant calculation error for the patient.It was noticed that the measurements were incorrect.It is unknown if the incorrect intraocular lens implant was implanted.Additional information has been requested but not received.
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Manufacturer Narrative
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The company service representative examined the system and replaced the biometry probe to resolve the issue.No issues were identified with the system.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The biometry probe serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause of the reported event is likely attributed to a nonconforming biometry probe.However, with the information provided for this investigation, this is unable to be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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