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Model Number OPO73 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Burn(s) (1757)
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Event Date 07/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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It was reported that patient felt heat while surgeon was sculpting a groove in a nucleus with ellips fx handpiece.Surgeon immediately took the tip off from the patient's eye.The incision in patient's eye received mild thermal burn.The surgeon checked the handpiece and confirmed the handpiece had become hot.Surgeon replaced with the phaco machine and equipment of another company¿s product, and the surgery was successfully completed.Surgeon used the us power 85% setting and fully applied the foot pedal when the issue occurred.Opo73 fusion dual pump pack was used for multiple procedures prior to the incident.Opo73 was discarded by the customer and no sample was going to be returned for investigation.There was no vitrectomy performed, no medication for thermal burn treatment was reportedly provided.Sutures were used to prevent further patient injury.The incision size was reported as 2.4mm.This report is for opo73 fusion dual pump pack.A separate mdr report is being submitted for ellips fx phaco handpiece system.No further information provided.
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Manufacturer Narrative
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Additional narrative information: section h6 coding.Type of investigation: 4112.Investigation findings: 4248.Investigation conclusions: 61.Investigation was completed with no product return as per complaint description, product was discarded and is not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Per complaint description, the issue occurred following the reuse of the opo73 that is designed for single use.Per z311154 rev b, dfu, opo73 (multilingual), "do not re-sterilize, reprocess, or reuse this device".All devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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