ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number TABLETOP |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Phototoxicity (2165)
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Event Date 11/30/2018 |
Event Type
Injury
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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 autofluorescence alterations were present postoperatively.Phototoxicity of the right eye is suspected.Additional information has been requested.
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Manufacturer Narrative
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The company representative determined that the ¿upper-light-source was used with a 23 gauge wide field probe in the first port during three surgeries for that same day (per event logs).The light was measured and fell within specifications.The company service representative examined the system in order to measure the illumination output, as well as the laser function per customer¿s request.The company service representative tested the system¿s tabletop illuminator and found ports 1 and 2 outputs to be 10 and 12 lumens, respectively.This meets the product specifications to be between 10-22 lumens.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.The system was found to meet relevant functional specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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