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Model Number NGP680301 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wrinkling (2613); Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Weight and ethnicity: unknown, not provided.Date of event is unknown.Best estimated dates are from march 2021 thru april 2021.Serial number is unknown as it was not provided.Unique identifier (udi) number unknown as serial number was not provided.Concomitant medical products: lens model dib or dcb unknown-right eye and lens model dcb0000225 sn: (b)(4) left eye.Manufacturer date is unknown as serial number was not provided.(b)(4).Although several attempts were made, the clinic is reporting this adverse event only and did not request or require field service or clinical support.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 several patients developed post-op complications after the implantation of dcboo and or diboo intraocular lenses with the use of the signature equipment.The date of surgeries was between january and april of 2021.The post op complications reported were edema with various grades, fibrin, cells graded from trace to 3+, folds with increase, and retinal hemorrhage.This report is for the following: a (b)(6)-year-old male developed cells in the anterior chamber, folds, and edema grade 4+ after cataract extraction and implantation of model dcboo and or diboo intraocular lens of on both eyes with the use of the signature pro equipment.It was indicated the left eye was at a grade +4 edema and the right eye was unspecified edema with folds and cells reported.Although several attempts were made, no service was requested and no additional information was provided.
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Manufacturer Narrative
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Additional information: section b5: through follow up, it was determined the patient experienced toxic anterior segment syndrome (tass).Section h6-health effect clinical code 4469 - toxic anterior segment syndrome (tass).Device evaluation: a johnson & johnson representative visited the site location.After discussions with the treating surgeon, the surgeon comments t are that believes this event is a sterilization issue with some of surgery center¿s instruments etc.The j&j representative reviewed the directions for use (dfu) of how to sterilize the handpieces with the administration of the operating room (or), staff, and surgeon.At this time, no further occurrences have been reported.As stated in initial report, 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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