Model Number PC-60R (19.50 D) |
Device Problem
Fracture (1260)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/27/2023 |
Event Type
malfunction
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Event Description
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Event occurred in brazil.Per distributor, event reported by hospital directly to anvisa in brazil cracked ordeformed cartridge / tip; lens injector cracked lens injector cracked during insertion of the lens making implantation of the lens impossible; patient impact: insufficient information.
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Manufacturer Narrative
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This initial emdr is being submitted to fda for outside us like products reporting.Injector malfunction is indicated as a potential malfunction related to the injector system, as covered under the warnings section of the product's instructions for use (ifu).Regarding section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
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Manufacturer Narrative
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This follow-up #1 emdr is being submitted to fda for an event that occurred outside of the usa.The report includes corrected and additional information not available/included in the initial report.Corrected information: d9 - corrected to no.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for corrected and additional information.H3 - indicated device not returned to manufacturer.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.No abnormalities were found in production and inspection records of the product.(serial no.:(b)(6); model: pc-60r).The exact root cause of the event was not determined.However, based on available information, we believe this event was not caused by our product quality.A review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.
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Event Description
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Event occurred in brazil - per distributor, event reported by hospital directly to anvisa in brazil cracked ordeformed cartridge / tip; lens injector cracked lens injector cracked during insertion of the lens making implantation of the lens impossible; patient impact: insufficient information.
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Search Alerts/Recalls
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