ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
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Catalog Number 8065977763 |
Device Problems
Break (1069); Device Damaged by Another Device (2915)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Event Description
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A facility representative reported that at the time of implantation of intraocular lens (iol), when the lens was displaced inside the cartridge by the delivery system, the cartridge suffers a break in its terminal portion that causes the lens to be held in this crack, making subsequent displacement impossible.It was resolved to remove the affected lens and implant another lens of the same model, also replacing the cartridge for it.Additional information has been received and stated that, there was patient contact with the device.
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Manufacturer Narrative
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Information provided in the file indicated that a qualified lens and viscoelastic were used with the company cartridge.A non-qualified handpiece was used.The root cause may be related to a failure to follow the ifu (instructions for use).A non-qualified company handpiece was used with the cartridge/lens combination.Per the ifu: the company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Per the company device dfu (directions for use): the qualified cartridge/iol combinations have been validated at an ambient temperature of 18 °c using the driving console setting (1.7 mm/sec, 3 seconds, and 3.0 mm/sec for initial velocity, pause and final velocity respectively).Using a higher velocity and shorter pause at lower temperatures, especially with high diopter lenses, could induce damage to iol and/or iol cartridge, affecting successful iol implantation.The manufacturer internal reference number is: (b)(4).
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