Model Number PCB00 |
Device Problem
Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that an intraocular lens (iol) misfired.It is unknown if there was patient contact.Through follow-up, it was learned there was patient contact and the product was discarded.No other information was provided.
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Manufacturer Narrative
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Device evaluated by mfr: other (81): the device was not returned for evaluation as it was discarded; 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, no definitive 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 info: further information was provided that there was patient contact, however, the iol was not inserted in the patient's right eye.There was no patient injury.There was no vitrectomy, incision enlargement, or sutures required.The replacement lens 23.0d was successfully implanted.The date of event, physician's name, and the patient's date of birth and gender were provided.The following sections have been updated accordingly: section a2: age/date of birth: (b)(6) 1960.Section a3: sex/gender: male.Section b3: date of event: nov 15, 2022 section e1: first/given name: (b)(6).Section e1: last name:(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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