Model Number SN60WF |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
Rupture (2208)
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Event Date 03/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: 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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.This product malfunction was originally reported under a voluntary summary report.New information was received which prompts assessment and expedited reporting.The updated information is being sent via this 3500a report.(b)(4).
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Event Description
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A facility representative reported that during an intraocular lens (iol) implant procedure, when they went to deploy the iol it malfunctioned.Additional information was provided that the capsule ruptured during the initial procedure.
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Manufacturer Narrative
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Product evaluation: the lens was returned in a qualified cartridge.Viscoelastic is observed in the cartridge.The lens is advanced between the loading area and the nozzle entry area.The lens and haptic positions are acceptable for advancement.The cartridge has evidence it was placed into a handpiece.No damage observed.All product and batch history records are quality reviewed prior to product release.No problem was found with the returned iol.The lens was returned advanced in a cartridge.The lens and haptic positions were acceptable for advancement.No damage was observed.It was initially reported that the iol malfunctioned.New information on the iol card states not implanted wasted - capsule ruptured.The lens could not have contributed to a capsule rupture as it has not been delivered.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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