Model Number PCB00 |
Device Problems
Break (1069); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Age/date of birth: unknown/not provided.Sex/gender: unknown/not provided.Date of event: unknown/not provided.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.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 that an intraocular lens (iol) was defective.The tip of the cartridge looked melted and deformed.Patient involvement is unknown, however, there was no surgical intervention required.The patient is doing fine post-operatively.No additional information was provided.
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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
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Manufacturer Narrative
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Device evaluation: the device was not returned at the manufacturing site; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints revealed two other complaints were received under this production order; however, product deficiency was not identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
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Search Alerts/Recalls
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