Model Number GIB00 |
Device Problems
Break (1069); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that the intraocular lens (iol) was implanted with a scratch because of the inserter that was not working well.The iol was removed and replaced during the same surgery.No further detail was provided.
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Manufacturer Narrative
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Section a2, a4 and a5: per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information 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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Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: jan 2, 2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the customer provided a photograph for evaluation.Displayed was an implanted lens and damage could be observed to the optic body.The nature of the damage could not be determined from photographic evaluation.The complaint lens was received cut in half with one half missing.The lens was cleaned and presented with no additional issue.No smartload device was received for evaluation.Per the definition of "cosmetic issues" , the complaint issue could not be confirmed.However, the observed issue "lens damaged" is similar to the complaint issue "cosmetic issues" and could not be confirmed to be related to the manufacturing or design process.The complaint issue "cartridge damaged" could not confirmed during product evaluation as no product was received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Corrected data upon further review, it was confirmed that the suspect product should have been the vitan inserter instead of the gib00i0180 - (b)(6).Therefore, this supplemental filing is to correct the following fields: section d1 - brand name : vitan.Section d2 - common device name : folders and injectors, intraocular lens (iol).Section d2 - device product code : mss.Section d3 - establishment name: (b)(4).Section d4 - model number : dk9000.Section d4 - catalog number : dk9000.Section d4 - lot number : 0063.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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