Age, weight, ethnicity: unknown/ asked but not available.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as serial number was not provided.Unique device identifier (udi #): unknown, as serial number was not provided.If implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted, give date: not applicable, as there is no indication that the lens was implanted.The device was not returned for analysis.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.Device manufacture date: unknown as serial number was not provided.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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Additional information: section b5: additional information received from the surgical facility revealed that there was no damage to the actual lens.The issue was that the lens guide was not properly and set did not lift the lens carrier.Once the lens was pushed forward, it did not engage with the cartridge.Corrected data: therefore, the current report captures the following correction: section d4: catalog number: dib00u0095.Section d4: serial number: (b)(6).Section d4: expiration date: jan 11, 2024 section d4: unique device identifier (udi #): (b)(4).Section h4: device manufacture date: jan 11, 2021.Section h6: medical device problem code: 2522 - failure to align.Section h6: medical device problem code: 1384 - mechanical problem.Additional information received confirmed that there was no damage to the actual lens; therefore, this report is no longer a reportable event and no further information will be provided under mfr report number 3012236936-2022-01703.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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