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Model Number OPOHF20L |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative information: 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.Date of event: unknown/not provided.Telephone number: (b)(6).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 a piece of opaque foreign matter entered patient's eye during irrigation/aspiration procedure.The foreign matter was immediately removed with forceps by the surgeon.Procedure was successfully completed with one minute delay.The foreign matter was collected.It was alleged that the foreign mater looked like a fragment originated from phaco tip sleeve.There was no patient injury.No further information provided.
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Manufacturer Narrative
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Device evaluation: a transparent particle was returned inside a sterile pouch, fixed in place with tape.No phaco sleeve or original packaging were returned.The particle was forwarded to an external lab for material analysis.The foreign material was identified as a silicone species similar to polydimethylsiloxane by comparison with a reference from eurofins eag's library.Without the sleeve being returned, the origin of the silicone particle cannot be determined.However, the opohf20l irrigation sleeve is violet in color.The returned particle is colorless, therefore it is unlikely that it originated from the sleeve.Manufacturing record review: a review of records related to the devices showed 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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