Model Number PCB00V |
Device Problems
Break (1069); Difficult or Delayed Positioning (1157)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).This report is being filed on an international device; tecnis optiblue 1-piece iol, model pcb00v that has a similar device, tecnis 1-piece iol model pcb00 which is distributed in the unites states under pma p980040.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 there was a little resistance when the plunger lock was released.Lens model, pcb00v monofocal iol (intraocular lens) was confirmed damaged after being inserted in patient's eye.As a result, the lens was removed by cutting with a lens cutter.Reportedly, there was no patient injury.No additional information provided.
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Manufacturer Narrative
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Device available for evaluation?: yes, returned to manufacturer on: 02/11/2019, device returned to manufacturer?: yes.Device evaluation: the intraocular lens was received at the manufacturing site for investigation.The pcb00 insertion device was received inside the original box on 02/11/2019.The plunger was observed in advanced position.The pcb00 device was observed under microscope and scarce amount of viscoelastic was observed at the cartridge.The directions for use (dfu) states to completely fill the viewing window of the pcb00 with ovd (viscosurgical device).There was no damage or errors observed on the assembly.The lens was received cut.The condition observed is consistent with a lens that has been removed/explanted.The reported issue was not verified.Manufacturing record review: a review of the manufacturing records was performed.The devices were manufactured within specifications.The units were released according to specification.Historical analysis: a search on complaints revealed that no other complaint has been received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, along with warnings for the proper use and handling of the product.Based on the results of the investigation, a product quality deficiency nor a product malfunction could be determined.All pertinent information available to johnson & 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 (b)(4) and capa-010215.
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Search Alerts/Recalls
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