JOHNSON & JOHNSON SURGICAL VISION, INC. VERITAS VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number VRT680300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/26/2024 |
Event Type
Injury
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Manufacturer Narrative
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Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable.The veritas machine is not an implantable device.Section d6b - explant date: not applicable.The veritas machine is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h6 -health effect - clinical code: 4581: hs-incision enlarged : 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.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 during the phaco procedure, using a veritas machine, the surgeon noticed a posterior capsule tear in the right eye and had to perform an unplanned vitrectomy.The surgeon had to enlarge the incision and apply sutures to the area.Subsequently, the patient had a sensar intraocular lens placed in the sulcus.The patient was recovering well at the one-day postoperative review.No additional information was received.
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Search Alerts/Recalls
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