Model Number DIB00 |
Device Problems
Crack (1135); Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that a partially inserted intraocular lens (iol) was removed from a patient¿s right eye as the cartridge broke/cracked, cartridge tip cracked/deformed.It was indicated that there was patient contact and the issue was noted while inserting the lens into the eye.The procedure completed successfully using a replacement lens of the same model and diopter.The outcome did not significantly interfere with patient's activities of daily life and the patient has recovered.No further information was provided.
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Manufacturer Narrative
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Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.Section h3-other (81): the device was 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.Section h6: medical device problem code: 1135 - crack (cartridge tip cracked/damaged & cartridge crack).An attempt was made to obtain the missing information; however, the information was not available.All pertinent information available to johnson & 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: returned to manufacturer on: may 2, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: handpiece was received in the handpiece tray in the original folding carton.Visual inspection under magnification revealed that the complaint handpiece was received in the handpiece tray suggesting that the plunger rod was fully retracted.The lens was found stuck in the tip of the cartridge.The cartridge and cartridge tip were deformed around the lens, no crack was identified.Trace amounts of viscoelastic residue could be identified in the cartridge that did not run the length of the cartridge, suggesting that an inadequate amount of ovd/bss may have contributed to the complaint and observed issues.The handpiece was disassembled and assembly was inspected.No issues were identified that could have contributed to to the complaint or observed issue.The lens was removed and cleaned revealing the trailing haptic was damaged.The complaint issues (cartridge crack and delivery issue) were not confirmed.The complaint issue (cartridge tip cracked/damaged) was confirmed.Based on the complaint investigation results the complaint issue and the observed issues could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
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Search Alerts/Recalls
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