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Model Number DIU150 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the tip of the preloaded intraocular lens (iol) device was kinked.Account indicated that only the cartridge tip made contact with the patient's right eye.There was no patient injury reported.No other intervention was required.The procedure was completed using another lens of same model and diopter.The patient was doing great post-operation.No further information was provided.
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Manufacturer Narrative
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If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted.The device was not returned for analysis.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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Manufacturer Narrative
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Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jul 8, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the handpiece was received with the lens stuck inside of the cartridge tip and with the plunger rod overriding the lens.The plunger rod could also be observed to have deformed and punctured the side of the cartridge and cartridge, in a way consistent with a handpiece that had excessive force applied to the handpiece.The handpiece was disassembled and the assembly was inspected, no assembly issues that could contribute to the observed issues could be identified.Conclusion: the reported complaint issue was observed during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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