Model Number 1MTEC30 |
Device Problems
Break (1069); Device Damaged by Another Device (2915)
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Patient Problem
No Code Available (3191)
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Event Date 08/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, if explanted, give date: not applicable as this is not an implantable device.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
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Event Description
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It was reported that surgeon had four cartridges which failed and required incision enlargement to implant intraocular lens.Reportedly the plunger rod went through the cartridge.This occurred four different times and cracked the cartridge in each case.No further information provided.This report captures the event for #2 of 4 devices.A separate report is being submitted for each device.
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Manufacturer Narrative
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Device available for evaluation; returned to manufacturer on: 9/9/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.Twenty-one unused cartridges were received in the original box.The cartridges were sealed with tyvek lids in their trays.The cartridge was evaluated under magnification.No damage was observed.The cartridge used on the surgical stage during the event reported was not received for evaluation; the reported issue could not be verified.Based on the analysis product, quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications a search on complaints revealed four (4) additional investigations, for this manufacturing lot cb41217.The dfu (direction of use) provides clear and adequate instructions.There is no potential risk to product or patient safety.In addition, a customer notification letter was generated to re-emphasize following the dfu instructions for the use of the coated cartridges.The investigations revealed no product deficiencies.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.
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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 (b)(4) and capa-010215.
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Search Alerts/Recalls
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