Model Number PCB00 |
Device Problems
Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
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Patient Problems
Macular Edema (1822); Visual Disturbances (2140); Prolapse (2475); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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Age/date of birth: ages are (b)(6).Sex/gender: for this case the gender is provided as both male and female in unknown numbers.Date of event: exact dates not provided, article acceptance date (b)(6), 2020.Serial number : unknown/not provided.Expiration date: unknown as the serial numbers were not provided.Unique identifier (udi) number: unknown as the serial numbers were not provided.Phone : (b)(4).Device manufacture date : unknown as the serial numbers were not provided.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Stanojcic, n., o¿brart, d., hull, c., wagh, v., azan, e., bhogal, m., robbie, scott., and li, j.O.(2020) visual and refractive outcomes and glistening occurrence after implantation of 2 hydrophobic acrylic aspheric monofocal iols, journal of cataract & refractive surgery, 46(7), pp.986-994 https://doi.Org/10.1097/j.Jcrs.0000000000000201 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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The following article was received based on a literature review: article: visual and refractive outcomes and glistenings occurrence after implantation of 2 hydrophobic acrylic aspheric monofocal iols.A prospective, single-center randomized controlled trial was done to compare the clareon intraocular lens (iol) with the tecnis pcb00 iol (johnson & johnson vision) in terms of visual performance, refractive outcomes, glistenings occurrence, and quality-of-life outcomes.Sixty eight patients (136 eyes) were randomized to the tecnis iol group.Perioperative complications occurred in the tecnis iol group include iris trauma/prolapse (n=1), retained cortical matter (n=1), angle trauma (n=1), stuck haptics (n=1), malpositioned haptics (n=1), and posterior capsule rupture (n=1).Post-operative complications occurred in the tecnis iol group include posterior capsular opacification (pco) (n=9 eyes), negative dysphotopsia (n=2 eyes), and cystoid macular edema (cme) (n=11 eyes).In addition, one (n=1) tecnis pcb00 iol developed grade 1 glistenings (between 1 and 10 glistenings/mm2).At 12 months, the mean manifest refraction spherical equivalent (se) error (d) was 0.02 ± 0.3; the mean absolute se refractive error from target refraction (d) was 0.25 ± 0.20; and the residual refractive cylinder was -0.74 ± 0.47 for the tecnis pcb00 iol group.Of the 9 eyes with pco, 2 eyes required nd:yag capsulotomy.Further interventions for the reported complications were not specified in the study.This report is to capture the reported adverse events.A separate report is being submitted for the reported product problems.
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Manufacturer Narrative
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Corrected data: section h6: as part of an internal review of our mdrs it was identified that the following codes should not have been indicated in the initial report.2923 - device dislodged or dislocated, 4012 - physical resistance/sticking.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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