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 three medical device reports associated with this event.This report is for 2 of 3.
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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 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 for lot # 15347781 was not returned.Eight unopened company cartridges were returned an opened 10-count carton.One of the returned company cartridges was opened and microscopically examined with no damage observed.No particulate was observed inside the cartridge lumen.The company cartridge was 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 cartridge was 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.The used company cartridge complaint sample was not returned.No determination can be made without physical evaluation of the complaint sample.One of the unopened company cartridges returned for the reported lot was evaluated.No foreign material was observed.Functional and dye stain testing was conducted with the unopened sample with acceptable results.No foreign material was observed after the functional testing.It is unknown if a qualified lens model/diopter and handpiece were used.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 three medical device reports associated with this event.This report is for 2 of 3.
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Search Alerts/Recalls
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