Model Number DCB00 |
Device Problem
Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2023 |
Event Type
malfunction
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Event Description
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It was reported that as the surgeon was positioning the inserter to place the lens into the patient¿s right eye, he advanced the intraocular lens (iol) and the lens ejected into the anterior chamber, and the surgeon was unable to maneuver it into the bag.The surgeon stated that he did not feel as though he was engaging the inserter to cause the early ejection of the iol.There was patient contact.Reportedly, the iol was removed, and a backup lens of the same model and diopter was implanted.There were no adverse events, no injury and no other medical intervention was required.It was indicated that the patient is doing well.No further information was provided.
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Manufacturer Narrative
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Unknown, information was requested but not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section h3: other 81: 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.Attempts have been made to obtain missing information; 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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Manufacturer Narrative
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Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: may 15, 2023 section h3: evaluated by manufacturer: yes.Device evaluation: the complaint handpiece was received for evaluation.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod in the advanced position.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Visual inspection of the complaint lens revealed that it was received coated in viscoelastic residue.The lens was cleaned and, no issues that could cause or contribute to the complaint issue were identified.The complaint issue could not be confirmed during product evaluation, and no issues were identified.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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