Catalog Number 8065977763 |
Device Problems
Defective Device (2588); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2022 |
Event Type
malfunction
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Event Description
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A physician reported during the intraocular lens implantation abrasion occurred in the cartridge.This abrasion has occurred several times.The abrasion adhered to the back of the iol and could only be removed with difficulty.Additional information has been requested.There are 3 medical device reports associated with this event.This report is for 3 of 3.
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The used complaint company cartridge was not returned.Eleven 10-count cartons for lot 15290047 were returned.Nine were unopened (90) and two were opened with (6) and (8) samples inside.One unopened company cartridge was randomly pulled from each returned unopened carton.One sample was taken from the opened cartons.The samples were numbered 1-10 for evaluation purposes.The ten returned company cartridges were opened and microscopically examined with no damage observed.No particulate was observed inside the cartridge lumens.The company cartridges were functionally tested per the instructions for use (ifu).No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A qualified viscoelastic was indicated.The lens model/diopter and handpiece were not provided.It is unknown if a qualified combination was used.The root cause for the reported complaint could not be determined.No determination can be made without physical evaluation of the complaint sample.Seven of the unopened company cartridges returned for the reported lot were evaluated.Functional and dye stain testing was conducted with the unopened samples with acceptable results.No foreign material was observed after the functional testing.Per the ifu: the company delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company delivery system.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.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information has been requested and received stating there was no injury or harm to the patient, the fibers came from the cartridge and got into the patient eye and were sucked out from the eye.There are 3 medical device reports associated with this event.This report is for 3 of 3.
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Search Alerts/Recalls
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