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Model Number EMERALDC30 |
Device Problems
Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Pt info: unknown/ not provided.If implanted, give date: not applicable, the cartridge is not an implantable device.If explanted, give date: not applicable, the cartridge is not an implantable device.Telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
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Event Description
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Customer reported that during the handling of the emerald cartridge, inserting methylcellulose and position the intraocular lens (iol), the cartridge was presenting rigidity while the iol was being inserted in the eye.Resulting in a torn optical part and the haptic was completely amputated.There was no reported patient impact.No additional information provided.
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Manufacturer Narrative
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Device evaluation: product testing could not be performed since at the time of this investigation, the product has not been received for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed one additional complaint folder for this production order number, dc-cartridge tip cracked/damaged.The condition reported for additional complaint folder is not related to the complaint issue reported.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
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Search Alerts/Recalls
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