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Model Number CNW0T5 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2022 |
Event Type
malfunction
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Event Description
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A physician reported after an iol was implanted, two line-like foreign materials were found on the back of the iol.When aspirated them by irrigation and aspiration (ia), one was removed, but the other was not.The surgery was completed without product replacement.The patient after surgery had no problems, including the va.Additional information has been requested and received which states the two line could also be referred to scratch.
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Video was provided confirming reported complaint.Video review: video shows iol(intraocular lens) implantation with company cartridge.Iol and cartridge preparation is not recorded.Iol is advanced at the depth guard, the position of the iol for the advancement cannot be confirmed, it appears to be acceptable.Iol is implanted and 2 lines/ marks are visible over the iol optic.One of the marks can be confirmed to be a foreign material on the posterior surface of the iol as the hcp(healthcare professional) is performing removal of the observed particulate, successfully removed.No confirmation can be made if the second mark is a scratch or a foreign material, hcp completes the surgery with mark/ line remaining over the iol optic.The complainant indicates the use of non company viscoelastic, which is not qualified to be used with associated company iol model.Based on our observation of the attached video, marks/ lines are observed over the iol optic post implantation.It is confirmed that one of the marks is foreign material which is removed during the surgery.The origin of the observed material cannot be confirmed from the video.No sample was returned for evaluation.No confirmation can be made if the second mark/line is a foreign material or a scratch.A definitive determination of damage cannot be made without the evaluation of the physical product.The customer states the use of non-qualified viscoelastic.The use of an unqualified ovd (ophthalmic viscosurgical device)may cause damage to the lens and potential complications during the implantation process.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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