ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS
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Model Number SN6AT4 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
Eye Injury (1845)
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Event Date 03/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There has been two other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Event Description
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A procedure manager reported that, during intraocular lens (iol) implant procedure, the incision was enlarged slightly and inserted into the eye, whilst injecting the iol into the eye the trailing haptic was torn from the optic.The surgeon then cut the iol out and asked for the backup lens.The surgeon asked for a cartridge and a blunt probe to push the iol down the cartridge and into the eye.Unfortunately, during insertion of the iol, the posterior capsule ruptured and an anterior vitrectomy was performed the procedure was completed and the patient was left without a lens implant with a view to return for a secondary lens implant at a later date.Additional information was requested.
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Manufacturer Narrative
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The product was not returned.Information was provided that a non-company delivery system and viscoelastic were used.Based on the information provided, the root cause for the reported events is related to a failure to follow the instructions for use (ifu).Information was provided by the surgeon that by the time they were operating on the final patient of the day, they had used all of the company preferred injectors and only had a non-company disposable injector left to use.The non-company injector severed the haptic resulting in the surgeon removing the lens and inserting the standby lens.Per the ifu: 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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