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Model Number B1PC (+16.50 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 06/12/2023 |
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, as covered under the warnings section of the product's instructions for use (ifu).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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Intra-operative complications: posterior capsule rupture, explantation while inserting the iol in the bag, the lens seemed unstable.After inspecting the posterior capsule, it was noted that the iol was through the posterior capsule.At that time, surgeon explanted the iol and,proceeded to do an anterior vitrectomy.The surgeon used another iol in the sulcus and the power was changed as well.The surgery was a success.Patient health was not impacted; patient has recovered and is fine.
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Event Description
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Intra-operative complications: posterior capsule rupture, explantation while inserting the iol in the bag, the lens seemed unstable.After inspecting the posterior capsule, it was noted that the iol was through the posterior capsule.At that time, surgeon explanted the iol and,proceeded to do an anterior vitrectomy.The surgeon used another iol in the sulcus and the power was changed as well.The surgery was a success.Patient health was not impacted; patient has recovered and is fine.
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Manufacturer Narrative
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This follow-up #1 emdr is being submitted to fda for an event that occurred inside of the usa.The report includes additional information not available/included in the initial report.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for additional information.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was not returned to the manufacturer.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: b1pc).From our investigation, we couldn't confirm the reported event.We assumed this event was not caused by our product quality.
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Search Alerts/Recalls
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