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Model Number OPOS20L |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2022 |
Event Type
malfunction
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Event Description
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It was reported that glittering foreign matters, which looked like small metal particulates, were observed in patient's eye after ultrasonic was used during procedure.The foreign matter was aspirated by irrigation/ aspiration, and the procedure was successfully completed.There was no patient injury.Reportedly the surgeon collected the alleged foreign matter, and the sample will be returned for investigation.Laminar flow phaco tip and guage irrigation sleeve and test both were re-sterilized and reused 2 times.Customer discarded the products; no product will be returned for investigation.This report will capture information for guage irrigation sleeve, a separate report will be submitted for laminar flow phaco tip.No further information was provided.
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Manufacturer Narrative
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Additional narrative information: patient demographic information requested but not available at the time of this report.Age at time of event: unknown/ not provided.Date of birth and gender: unknown/ not provided.Patient weight: unknown/ not provided.Ethnicity and race: unknown/ not provided.Telephone number: (b)(6).Device evaluation: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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