Model Number MA60AC |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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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 manufacturer internal reference number is:(b)(4).
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Event Description
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A healthcare professional reported that, during intraocular lens implantation surgery, the lens was damaged during the surgery.The surgery was completed using standby lenses.No patient impact was reported.
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Manufacturer Narrative
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The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The lens model is only qualified for use in the company cartridges.The product investigation could not identify a root cause for the reported complaint.The product has not been received to evaluate.Associated products were not provided.It is unknown if qualified products were used.The ifu instructs: company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Follow up attempts were made.No further information has been provided at this time.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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