Model Number PCB00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Visual Impairment (2138); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown, not provided, but the best estimate date is (b)(6) 2018.(b)(4).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 patient had decreased visual acuity after the implantation of pcb00 +29.5 diopter tecnis monofocal iol (intraocular lens).As a result, the lens was explanted and replaced with another lens, same model smaller diopter (+28.0).No incision enlargement, no vitrectomy was performed and no sutures were used.No additional information was provided.
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Manufacturer Narrative
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Device available for evaluation? yes.Returned to manufacturer on: 01/17/2019.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.The lens was observed under the microscope and it was observed cut in four pieces with both haptics detached.The condition observed was typical of an explanted lens.The customer's reported complaint could not be verified.A product quality deficiency was not identified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
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Search Alerts/Recalls
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