Catalog Number 8065977763 |
Device Problem
Particulates (1451)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that during an intraocular lens (iol) implant procedure, white substance found on lens.The iol was implanted and left inside the patient.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.There are three medical device reports associated with this event.This is file 2 of 3.
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Manufacturer Narrative
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The company cartridge was not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.A qualified handpiece 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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