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Model Number DIU225 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Blurred Vision (2137); Visual Disturbances (2140)
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Event Date 03/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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Requested but not provided.The device was not returned for evaluation; 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.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that the patient was experiencing poor quality of vision described as being hazy and flickering in their left eye (os) resulting in the need for an explant.The intraocular lens (iol) was replaced with a model zcu225, 22.5 diopter iol.There was no reported patient injury and no other surgical or medical intervention required.Patient is reported to be doing much better after the iol exchange (no 20/20 uncorrected).Pre-op uncorrected visual acuity- unknown.Best corrected pre-op 20/30.Post-op uncorrected and best corrected visual acuity: 20/40 and 20/25-2.Intended/targeted post-operative refraction: plano.No additional information was provided.
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Manufacturer Narrative
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Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 9/8/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of a specimen cup.Visual inspection under magnification revealed that the complaint lens was received cut into three pieces.The lens was cleaned and, no issues were observed that could contribute to or cause blurry vision were identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue ¿hm-blurry vision¿ and ¿hm-visual disturbance¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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