ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
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Catalog Number 8065977763 |
Device Problems
Crack (1135); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2023 |
Event Type
malfunction
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Event Description
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A non-healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, when the injector was inserted into the cornea, the doctor noticed that the cartridge was cracked in the middle, the implantation was carried out without further problems, but the doctor noted that the implantation process was more difficult when screwing in and the plunger pushed the lens in a way different and not as smooth as in a normal transplant.Additional information was requested.There are two medical device reports associated with this patient.This report is 1 of 2.
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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.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The used company cartridge was not returned for evaluation.Eight unopened company cartridges were returned for the reported lot (6 unopened 10-count cartons and 20 unopened sample in baggies).This lot was related to two files from this facility.The evaluation will be placed in both records (b)(4).One sample was pulled randomly from each returned carton and bag.The eight unopened company cartridge samples were opened and microscopically examined with no damage or abnormalities observed.The eight company cartridge samples were functionally tested per the instruction for use (ifu).No lens or cartridge damage was observed after the lens deliveries.The company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Qualified associated products were indicated.The used company cartridge complaint sample was not returned.No determination can be made without physical evaluation of the complaint sample.Eight 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 lens or cartridge damage was observed after the lens deliveries.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices (ovds), 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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Search Alerts/Recalls
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