Model Number SN6AT4 |
Device Problems
Defective Device (2588); Scratched Material (3020)
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Patient Problems
Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2021 |
Event Type
Injury
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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 an intraocular lens (iol) implantation procedure, the iol was damaged.There was difficulty with insertion and the lens was not placed.Additional information has been requested however, further information has not been received.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received indicating difficulties with placing the lens in the cartridge correctly, the lens was found to be scratched following insertion in the eye.The incision size was increased and the lens was removed.The iris herniated and a partial iridectomy was performed.The iol was replaced and the procedure was completed.The following day the patient's intraocular pressure was high.Further information has not been received.
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Manufacturer Narrative
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Product evaluation: the product was returned for analysis and the reported complaint was observed.There have been no other complaints for this lot.Additional observations were as follows: iol returned cut in half in iol case.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned.The optic is torn/split-cut dividing the iol in two(2) and scratched/marked-rejectable.Additional information: the complainant states the use of non company cartridge which is not qualified to be used with the associated iol model/viscoelastic combination.Root cause: while we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow dfu, as the customer states the use of non-qualified combination.The use of nonqualified combination may result in delivery issues and/or damage.The product was subject to handling and the reported damage was highlighted post implantation.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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