Catalog Number 8065977763 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2021 |
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 physician reported that, while intraocular lens (iol) implantation it was noticed that, there was a white stringy substance on the left side of lens on cartridge end.White debris was seen again as lens unfolded.Additional information has been requested; however, further information has not been received.
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Event Description
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Additional information was received, by health professional.That the cartridge had substance either within the device itself, or in one instance had a hard piece of plastic stuck to the end.As if it wasn¿t properly cut, during manufacturing.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The company cartridge was not returned for evaluation.Photos were provided of a lens in the eye and one still in a cartridge.It cannot be determined if all photos are for this specific file.No determination as to the origin or nature of the reported material can be made from the provided photos.A qualified headpiece and viscoelastic were indicated.It is unknown if a qualified lens model/diopter was used.The product investigation could not identify a root cause for the reported complaint.No determination can be made without physical evaluation of the complaint sample.Per the ifu (instructions for use): the company iol delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of 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.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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