Model Number ZCW300 |
Device Problem
Unstable (1667)
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Patient Problems
Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Phone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it was discarded after it was explanted; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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Initially, it was reported that an intraocular lens (iol) axis deviated by 90 degree six months after the cataract surgery ((b)(6) 2021).An operation was performed to correct the lens deviation.On (b)(6) 2021, the patient complained of poor vision when they visited the clinic.A slit lamp revealed that the axis deviated by 90 degree.The lens was explanted in a secondary surgical procedure and the product was discarded.A non-toric one-piece replacement lens from another company was used.It was indicated that the surgeon noticed that the iol did not adhere to the capsule which is usually seen after implanting a lens.The axial length: 27 mm.There was no patient injury reported after the lens replacement.No further information was provided.This emdr report captures the second event of lens rotation and an explant of the lens in a secondary surgical procedure.A separate emdr report is being submitted for the first event of lens rotation and repositioning.
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Manufacturer Narrative
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Corrected data: in review, it was noted that the code (2271) was inadvertently entered in the section 'h6- health effect - impact code' of the initial mdr report which is incorrect.The correct code that should have been entered is '2137' which has been captured in this supplemental mdr report.The following field was updated accordingly: section h6: health effect - clinical code: 2137.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Corrected data: in review, it was also noted that section "g2" should have included "company representative" which inadvertently was not selected in the initial mdr report, and that the patient's ethnicity and race were inadvertently not entered in the section "a5" of the initial mdr report.Therefore, the corrections have been made in this supplemental mdr report and the following fields were updated accordingly: section h6: as part of an internal review of our mdrs it was identified that the code "4582-no clinical signs, symptoms or conditions " provided in the section "h6-health effect - clinical code" of the initial report needs to be removed as it should not have been indicated in the initial report.Section a5: ethnicity: not hispanic/latino.Section a5: race: asian.Section g2: report source added: company representative.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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