ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
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Model Number AU00T0 |
Device Problem
Break (1069)
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Patient Problems
Corneal Edema (1791); Tissue Damage (2104)
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Event Date 02/18/2020 |
Event Type
Injury
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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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that during an intraocular lens (iol) implant procedure, both haptics were tucked on top of the optic in a correct manner, but upon inserting the lens in the eye, the trailing haptic broke completely from the optic.An enlarged incision was required to remove and replace the iol, and the procedure was completed by suturing the main incision.Additional information was received indicating at the one week follow up, the patient was recovering well with good visual acuity and mild corneal edema.
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Manufacturer Narrative
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Product evaluation: 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.The root cause may be related to a failure to follow the dfu.A non-qualified viscoelastic was used in the device.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the dfu, only qualified viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the dfu and is not recommended under any circumstance.Additional information provided in h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).
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