Model Number III |
Device Problems
Device Damaged by Another Device (2915); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The lot number was not provided.The manufacturer internal reference number is: (b)(4).
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Event Description
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A purchasing agent reported that during implantation of an intraocular lens (iol) the lens came out weird in eye and was scratched in injector.Additional information was received reporting inserter bent caused lens to twist and scratch.Lens removed immediately replaced by a backup lens.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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One opened company injector was returned for evaluation for the report of the lens came out weird in the eye and was scratched, the injector was also bent.A visual inspection of the iol company injector was performed and was found to be nonconforming.The plunger is bent downward at the plunger head.A functional thread to barrel engagement check was performed and was found to be conforming.Finally, a dimensional plunger position height check was performed and was found nonconforming due to the bent condition of the plunger.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The evaluation does confirm the injector plunger has a bent plunger head resulting in a downward plunger position.The root cause for the nonconforming plunger height is unknown.How and when how the plunger position became damaged cannot be determined from this evaluation.The most likely cause of a bent plunger head of the injector is from improper handling of the product.This injector has been in service for approximately 5 years.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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