Model Number AU00T0 |
Device Problems
Unintended Ejection (1234); Difficult to Fold, Unfold or Collapse (1254)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported during the intraocular lens implantation the lens could not be properly folded and was not advanced completely.There was patient contact.The surgery was completed after replacing the product with another one.There was no harm to the patient.Additional information has been requested and received stating there was no postoperative inflammation or complications.The patient visual acuity has improved and there were no health problems.
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Manufacturer Narrative
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The product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported during the intraocular lens implantation the lens could not be properly folded and was not advanced completely.There was patient contact.The surgery was completed after replacing the product with another one.There was no harm to the patient.Additional information has been requested and received stating there was no postoperative inflammation or complications.The patient visual acuity has improved and there were no health problems.
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Event Description
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Additional information was received stating there was patient contact.The lens inserted and removed from the eye during the surgery.
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Manufacturer Narrative
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The device and the lens were returned inside the opened blister tray in the opened carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.No damage was observed to the device.The lens was returned adhered in dried viscoelastic to the interior of the opened blister tray.Viscoelastic and blood were observed dried on the lens.The optic has a cracked area on the posterior surface near the edge.The lens was cleaned with klrp for further evaluation.A fold test was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.A non-qualified viscoelastic was indicated.The lens was returned outside of the device.A small cracked optic area was observed.A fold test was conducted with no difficulty.The root cause for the complaint of "iol could not properly folded and could not be advanced completely" may be related to a failure to follow the ifu.A non-qualified viscoelastic was indicated.The instructions for use instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device should be used.The use of an unqualified viscoelastic 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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Search Alerts/Recalls
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