Model Number ACU0T0 |
Device Problem
Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/18/2022 |
Event Type
malfunction
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Event Description
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A health professional reported that during an intraocular lens (iol) implant surgery upon insertion in to the patient eye, plastic residue was noticed.They had to explant the lens and insert a new one.Additional information received and stated that it felt and looked as if the lens grated as it went through the injector and then had ¿shavings¿ on the edge.Which tried to hose/ wash off but couldn¿t so did a lens exchange.
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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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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.A non-qualified viscoelastic was indicated.There are no other complaints in this lot.The root cause may be related to a failure to follow the ifu (instruction for use).A non-qualified viscoelastic was indicated.The ifu instructs: during device preparation and implantation of the company iol with the preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Only the used device was returned inside the opened carton with some of the inner packaging components.The lens was not returned for an evaluation.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The beveled anterior tip of the nozzle was bent backward as if in contact with a hard surface.The interior coating appears to be disrupted at the damaged area of the nozzle tip exit.The lens was not returned for an evaluation of the reported "shavings on the edge".Based on information in the file and evaluation of the returned used device, the root cause may be related to a failure to follow the instruction for use (ifu).The ifu instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.The manufacturer internal reference number is: 2022-17208.
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Search Alerts/Recalls
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