Model Number OPO73 |
Device Problem
Complete Blockage (1094)
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Patient Problem
Eye Burn (2523)
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Event Date 02/15/2024 |
Event Type
Injury
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Manufacturer Narrative
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Section a2 a3, a4 and a5: unknown/ not provided.Section h4 device manufacture date; unknown/not available at the time of this report.Section h3-other (81): 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.H3 other text : see h10.
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Event Description
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It was reported that there was a clogging issue with opo73 tubing and as a result a corneal burn occurred.No additional information was provided.
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Manufacturer Narrative
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Additional information: section a2 age/date of birth: 72 years, dob 02/16/1952.Section a3 gender: female.Section a4 weight: 187.Section a5 ethnicity: hispanic.Section b3 date of event: (b)(6) 2024 through follow up it was learned that the event occurred on patient's right eye.No secondary surgical intervention was needed.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: the manufacturing date for the device is nov 5, 2023.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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