Catalog Number 8065977763 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported that during an intraocular lens (iol) implant surgery, the cartridge burst during implantation of the lens.The lens was able to be implanted however the lens has abrasion.There was no impact on the patient.This is one of several reports from this facility.Additional information has been requested.
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Manufacturer Narrative
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A used company iii (d) cartridge was returned.Viscoelastic is dried in the cartridge.The cartridge nozzle has heavy stress.The nozzle is also cracked on the right side which split as it moved into the thinner tip.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Damage was observed to the interior surface at the area of the split.The company product history records were reviewed documentation indicated the product met release criteria.The associated iol is qualified for use with the company iii (d) cartridge.There are two non-company handpieces that have the designation provided.Only one has been qualified by alcon for use with the company iii (d) cartridge.Without the specific model number it cannot be determined if the qualified model was used.The company iii (d) cartridge exhibited heavy stress and was cracked in the thick cone area of the nozzle which split as it entered the thinner tip.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced and not an immediate ¿burst¿ event, unless the lens was advanced at a very fast rate.The root cause may be related to a failure to follow the dfu.The customer indicated the use of a viscoelastic, which is not qualified for the lens/monarch/handpiece combination used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.There are two non-company handpieces that have the designation provided.Only one has been qualified by company for use with the company iii (d) cartridge.Without the specific model number it cannot be determined if the qualified model was used.The use of non-qualified combinations may lead to delivery issues and/or damage to the lens or the company cartridge.The observed cartridge damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; or if the handpiece plunger is not positioned correctly at the trailing optic edge.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge causing damage.Top coat dye stain testing was conducted with acceptable results.There have been no changes to the manufacturing process for company iii (d) cartridges.The related iol file reported that the lenses "felt harder".The report of lens "felt harder" could be related to temperature of the operating room/or viscoelastic.The dfu instruct to use viscoelastic qualified for use that has been allowed to come to the operating room temperature to fill the cartridge before loading the lens.If the operating room temperature is too low (< 18°c / 64°f), lens folding and advancement may be more difficult.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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