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Model Number DIU150 |
Device Problems
Mechanical Problem (1384); Scratched Material (3020)
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Patient Problem
Blurred Vision (2137)
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Event Date 01/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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If explanted; give date: n/a (not applicable).The lens remains implanted.Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was initially reported that when using a preloaded intraocular lens (iol), the lens got stuck going through the injector and was subsequently scratched upon implant.The lens remains implanted; however, the surgeon is planning on doing a lens exchange on a later date.No other information was provided.Through follow-up further information was provided clarifying that when the iol stuck in the injector the plunger overrode the lens.Once inserted, a scratch was noted in the middle of optic.Post-implant the patient experienced blurry/distorted vision in the left eye.The patient¿s visual acuity (va) pre-operative (op): best-corrected visual acuity (bcva) 20/50, uncorrected visual acuity (ucva) 20/400, va post-operative: 20/60.The lens exchange is planned for (b)(6) 2022.No other information was provided.
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Search Alerts/Recalls
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