Model Number RAO610T |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Visual Impairment (2138)
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Event Type
malfunction
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Manufacturer Narrative
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The reference c21032 has been allocated to this case by rayner.The patient underwent implantation of the rayone toric rao610t iol on (b)(6) 2021.Post-operatively, the patient presented with a refractive surprise of +11.75/+0.50 x 167.On (b)(6) 2021, rayner were advised that the patient had re-visited the healthcare facility and undergone further assessment.The information received stated "her iol is central in the bag with normal macular on (b)(6) repeated biometry and her iol power calculation is essentially the same pre and post-op.Rayone toric se: +21.5 cyl: 1.50d was implanted.Iol aligned at 10 deg today vs intended alignment at 8 deg".The healthcare facility suspects that the implanted lens is not of the labelled power (se +21.5 d, sph +20.75 d, cyl +1.5 d).The rayone toric rao610t iol was explanted on (b)(6) 2021.The lens was cut in half to aid explantation.The explanted lens was retained and returned to rayner.The lens has been sterilised and power analysis is pending, the results will be provided in a follow-up report.This is an isolated report no other reports, of any type, have been received against the rayone toric rao610t batch 030151747.
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Event Description
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On (b)(6) 2021, rayner intraocular lenses limited received notification from its (b)(6) distributor of an event that occurred following implantation of a rayone toric rao610t.The event description provided states that post-operatively the patient presented with a refractive surprise of +11.75/+0.50 x 167.
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Manufacturer Narrative
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The reference (b)(4) has been allocated to this case by rayner.The patient underwent implantation of the rayone toric rao610t iol on (b)(6) 2021.Post-operatively, the patient presented with a refractive surprise of +11.75/+0.50 x 167.On (b)(6) 2021, rayner were advised that the patient had re-visited the healthcare facility and undergone further assessment.The information received stated "her iol is central in the bag with normal macular on oct.Repeated biometry and her iol power calculation is essentially the same pre and post-op.Rayone toric se: +21.5 cyl: 1.50d was implanted.Iol aligned at 10 deg today vs intended alignment at 8 deg".The healthcare facility suspects that the implanted lens is not of the labelled power (se +21.5 d, sph +20.75 d, cyl +1.5 d).The rayone toric rao610t iol was explanted on (b)(6) 2021.The explanted lens was retained and returned to rayner.Testing was completed on 12th february 2021.Testing of the returned explanted lens confirms the power of the lens is not as labelled (rayone toric rao610t +21.5 d / +1.5 d).The lens was cut into two pieces to facilitate explantation therefore the accuracy of the measurement has been slightly constrained.Our optics team confirm the power measurement to be correct to within ± 1.0 d; the lens was found to be in the region of +0.5 d.Rayner's production process includes a 100% lens optical power check and a 100% check of optical quality via mtf (modulation transfer function); both checks are carried out in accordance with the requirements of iso 11979 (ophthalmic implants -intraocular lenses).After power and mtf determination, lenses are passed into our clean room, where they are individually checked for cosmetic flaws and sealed into primary packaging, labelled, and then transferred to the autoclave for sterilisation.Our root cause investigation has concluded that a single rao610t lens with a power of +0.5 d from the batch processed immediately before rao610t batch 030151747 was inadvertently transferred into the rayone toric rao610t +21.5 d batch 030151747.Enhanced reconciliation and line clearance procedures were introduced into rayner's manufacturing process in september 2020.The rayone toric rao610t subject to this report was manufactured in march 2020 and pre-dates the implementation of enhanced reconciliation and line clearance procedures.
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Event Description
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On 21st january 2021, rayner intraocular lenses limited received notification from its (b)(4) distributor of an event that occurred following implantation of a rayone toric rao610t.The event description provided states that post-operatively the patient presented with a refractive surprise of +11.75/+0.50 x 167.
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Search Alerts/Recalls
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