Model Number PY-60AD (+18.00 D) |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/12/2022 |
Event Type
malfunction
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Event Description
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Event occurred in (b)(6).Incorrect information noted on outer box label.Outer box contained a lens with incorrect serial numbers.Patient impact: unknown; insufficient information.
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Manufacturer Narrative
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This initial emdr is being submitted to fda for outside us like products reporting.Manufacturer's codes for: type of investigation, findings, and conclusion are pending device return and completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
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Event Description
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Event occurred in new zealand incorrect information noted on outer box label.Outer box contained a lens with incorrect serial numbers patient impact: unknown; insufficient information.
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Manufacturer Narrative
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This follow-up #1 emdr is being submitted to fda for a reportable event that occurred outside of the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: h3 - corrected to yes additional information: d9 - added date returned e1 - added hospital information g6 - type of report - noted as follow-up #1 h2 - type of follow-up - noted for corrected information and additional information h6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.See attached file for details of the investigation.
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Search Alerts/Recalls
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