Model Number ZCU300 |
Device Problem
Application Program Problem: Dose Calculation Error (1189)
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Patient Problem
Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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Additional information: weight and ethnicity is unknown as information was asked, but not provided.Date of event: unknown as information was not provided, the best estimate date is between (b)(6) 2022.The device was not returned for analysis.Therefore, a visual analysis of the complaint device cannot be completed.A review of the device history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.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 reported the zcu300 21.5 diopter intraocular lens (iol) was explanted from the patient's ocular dexter (right eye) due to a power variance with previous lasik and replaced with a zcu150 22.0 diopter iol.There was no patient injury, no enlargement and no suture.Patient outcome was reported as fine.No further information is available.
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Manufacturer Narrative
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Upon further review, it was noted that in the initial mdr section g-4 combination product information was inadvertently not captured.Therefore, this supplemental filing is to correct the combination product that was not originally captured.Section g-4 combination product: no.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 04-jan-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could cause or contribute to the complaint issues could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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