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 04/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that the surgeon began inserting the tip of the inserter in the patient¿s right eye and while doing so, noticed that the lens had come out of the tip of the inserter.The surgeon was unable to proceed with using that lens for surgery as he was unable to get through the opening with an exposed lens.It was confirmed that there was patient contact with the device.It was indicated that the patient had a previous vitrectomy in the surgical eye, and it was noted that the eye was very soft.A backup lens of the same model and diopter was used, and the surgery was completed without further complications which no vitrectomy required, and no sutures were placed.It was confirmed that there is no medical/surgical intervention expected in the future either.No further information was provided.
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Manufacturer Narrative
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Section a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.Section h3-other (81): 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.An attempt was made to obtain missing information; however, the information was not provided.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: additional information received from the customer indicated that the patient had a vitrectomy prior to the date of this surgery.It was noted that due to the prior vitrectomy the eye was soft, but this vitrectomy was not done at the customer's facility.The customer also confirmed that there were not capsule tears that were noted by the physician.Section d9: device available for evaluation: yes section d9: returned to manufacturer on: (b)(6) 2023 section h3: device 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 an 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.No iol was received as part of this return.The complaint issue (uncontrolled delivery) was not confirmed and could not be confirmed to be related to a manufacturing or design issue.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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