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Model Number OPO73 |
Device Problems
Reflux within Device (1522); Suction Problem (2170)
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Patient Problem
Eye Injury (1845)
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Event Date 12/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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Section a2 and a4: unknown, as information was requested but not provided.Section d6a implant date: not applicable.Product is not an implantable device.Section d6b explant date: not applicable.Product is not an implantable device; therefore, not explanted.Section e1 telephone number: (b)(6).Section h3 other (81): the opo73 fusion dual pump pack was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that the handpiece got detached from the tubing unit during phacoemulsification procedure, resulting in insufficient reflux and the iris being accidentally being aspirated.It became difficult to perform the surgery, and although the crystalline lens was cleaned, an intraocular lens (iol) could not be implanted, so an iol will be implanted at a later date.No further details were provided.
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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: 18-jan-2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: one (b)(6) phaco tubing pack received within a bag.The lot number could not be confirmed.A visual inspection of the returned product reveals the bottle spike tubing had been cut.No other obvious defects or damages were observed.Due to the condition of the returned product, further functional testing could not be performed.The reported event could not be confirmed.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 and johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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