Catalog Number 8065752201 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2021 |
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 surgeon reported when aspirating the ophthalmic viscoelastic device (ovd), the aspiration worked slower than usual during the prephaco phase of a cataract procedure.The situation improved and the procedure was completed when the system mode was changed from prephaco to visco, then recharged from visco to prephaco.There was no harm to the patient.
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Manufacturer Narrative
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The product id was functionally tested for occlusion and was found to be conforming, there was a good flow of water passing though the distal tip of the phaco.The complaint evaluation confirms the product aspiration bypass (ab) hole inner diameter was occluded with foreign material.The foreign material was analyzed using and no good match was found.Sem/eds analysis which found the material to be primarily dried salts; however the exact identity is unknown.Salts are not a material that is used in the manufacturing process or packaging process of products.How and when the phaco aspiration bypass (ab) hole inside diameter became blocked with dried salts cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.The most likely source of the foreign material is surgical material.No specific action with regard to this complaint was taken because the source of the foreign material is not related to any manufacturing process.All products are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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