Model Number DXR00V |
Device Problems
Break (1069); Crack (1135); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Section a2, a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted.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.H6- 3191 for dissatisfaction.Attempts have been made to obtain missing information; however, to date, no 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 by the doctor that he experienced a malfunctioning preloaded intraocular lenses (iol).The iol had a crack in the cartridge and also a crack in the optic itself.Doctor expressed dissatisfaction with the simplicity system.No further information is available.This report belongs to the second among the four intraocular lenses.Separate reports are being submitted for each intraocular lens.
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Manufacturer Narrative
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Device available for evaluation: yes returned to manufacturer on: 10/2/2023 device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod fully advanced.The complaint cartridge was received with stretch marks located in the cartridge tip.However, stretch marks are considered within specification for a used cartridge.Further inspection of the cartridge revealed that there was viscoelastic residue dispersed throughout the cartridge, suggesting that an adequate amount of ovd/bss was used.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Conclusion: the complaint issue cartridge crack, lens damaged, and dissatisfaction - quality/design was not confirmed during product evaluation.As per complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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