Model Number DIB00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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If implanted, give date: not applicable, as lens was removed during the same procedure.If explanted, give date: not applicable, as lens was removed during the same procedure.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).An attempt has been made to obtain missing information; however, no definitive response has been received.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 the intraocular lens (iol) was not used.There was patient contact, but no harm reported.Not a miscalculation or improper fit.The lens was not placed.The incision was enlarged and a vitrectomy was performed.No zonules, unstable chamber reported.No other information was provided.
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Manufacturer Narrative
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Additional information: section b5: additional information received from the doctor indicated that the left eye capsular bag would not inflate despite irrigation.The chamber was noted to be unusual even prior to the insertion of the lens.The capsular instability was confirmed after the insertion of the lens when the lens would not stay centered.That initially there was no capsular tear.The vitreous was coming around the capsular bag due to missing zonules.It was noted that the vitrectomy and incision enlargement performed were unplanned.Although it was stated no known pre-existing issues that indicated zonule issues; however, later, the doctor confirmed that patient¿s pre-existing issues contributed to the reported event of instable chamber requiring vitrectomy and incision enlargement.It was noted that there was no patient injury, the patient was left aphakic, however, for the potential secondary intraocular lens (iol) placement in the future.Section a5: ethnicity: not hispanic/latino.Section a5: race: black or african american.Corrected data: in review, it was noticed that the code 2698 was not addressed in the section h10 of the initial mdr report and it was also noted that the "eye anatomy issue" that was used in the initial mdr report would not apply to this event and should not have been coded for.Therefore, the information has been corrected in this supplemental mdr report as indicated below section h6: health effect clinical code: 2698 (capsule collapse & zonular dehiscence).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: upon further review it was noted that "g4" field which should have been populated with "no" was inadvertently left blank on the initial mdr; therefore, the information has been corrected in this supplemental mdr report and the following field has been updated accordingly: section g4: combination product: no.Upon further review of the event, it was also noticed that since the account indicated that the patient¿s pre-existing issues contributed to the reported event of instable chamber requiring surgical interventions and as the reported event was not due to the lens product problem or malfunction, therefore, the event is no longer reportable and no further information will be provided under this manufacturer report number.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
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Search Alerts/Recalls
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