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Model Number EMERALDC30 |
Device Problems
Material Opacification (1426); Scratched Material (3020)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported by the doctor that he first noticed lathe lines on the ar40 lenses for the first time a while back.At the beginning of (b)(6) he sent pictures of an ar40 iol that he pushed through the emeraldc injector in vitro and took to the slit lamp, with same issue as before.Both these reports have been captured in 2 different complaint folders.Another report received that the doctor has sent a picture of a patient with capsular fibrosis that he plans to treat with the yag laser.The patient was operated on two weeks ago.Pictures of the capsular fibrosis and lens scratches are visible.Lens remain implanted.Through follow-up it was learnt that the emerald cartridges caused the scratches.It was noted that these cartridges are stored at about 20 degrees celsius.No further information has been provided.
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Manufacturer Narrative
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Pt.Info.: information unknown/not provided.Per eu regulation 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: exact date is unknown/not provided.Best estimate is during (b)(6) 2022.Lot l#: the lot number for the cartridge involved in this specific case is unknown-not provided.However, based on the delivery dates provided by customer, the following is a list of the lot numbers for all cartridges provided over the past year: ch12429, ch19316, cj14709, cj17495, cj24921, cj24922, cj26367 and cj30144.Catalog number: a complete catalog number is unknown, as product lot number was not provided.Expiration date: unknown as product lot number was not provided.Udi number: a complete udi number is unknown as product lot number was not provided.If implanted, give date: n/a (not applicable).The cartridge is not an implantable device.If explanted, give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.(b)(6).The device has not returned for evaluation.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.Device manufacture date: unknown, as the lot number was not provided.(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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Manufacturer Narrative
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Corrected data: upon review of the file on 05-apr-2022 it was noticed that the following sentences was inadvertently missing from the previous report: subject matter experts assessed the photos and the observations could potentially be caused by glycerol monostearate (gms) residues on the lens surface.Gms is used as lubricant in the inserter at manufacturing to facilitate the intraocular lens moving through the system.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 noted that the code (4581) was inadvertently entered in section "h6 - health effect - clinical code" of the initial mdr report, which is incorrect.Also, it was noted that an incorrect verbiage for section "h3-81" was inadvertently used in the section "h10" of the initial mdr report; therefore, the information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section h6 - health effect - clinical code: 4582.Section h3-81 (other): the device has not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.As the lot number of the device is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Section h6: the medical device problem code was corrected to 1426 - material opacification.Based on further review of the reported issue it was determined that this is the more appropriate code.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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