Model Number PREVUE C (+24.50 D) |
Device Problem
Sharp Edges (4013)
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Patient Problems
Failure of Implant (1924); Capsular Bag Tear (2639)
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Event Date 05/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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This initial emdr is being submitted to fda as a reportable event that occurred in the usa."posterior capsule rupture" is indicated as a potential adverse event related to iol implantation in hoya ifu covered under the warnings section.Regarding section h6 - 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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Capsular bag tear; upon insertion of the iol the capsular bag was torn and anterior vitrectomy had to be performed.Product replaced with another lens immediately during surgery.
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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 in the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: d3 - corrected manufacturer's us address to new location.G1 - corrected manufacturer's us address to new location.H3 - corrected to yes.Additional information: g2 - added company representative for investigation.G6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for corrected 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.Injector and iol were available for investigation.No abnormalities were found in production and inspection records of the product.(serial no.: 8cw20ah1; model: prevue c).From our investigation, we could not confirm the reported event.Based on available information, we believe this event was not caused by our product quality.A review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.
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Event Description
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Capsular bag tear; upon insertion of the iol the capsular bag was torn and anterior vitrectomy had to be performed.Product replaced with another lens immediately during surgery.Health impact: device explantation; modified surgical procedure.
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Search Alerts/Recalls
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