Model Number 1MTEC30 |
Device Problem
Contamination (1120)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/20/2020 |
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.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device.An attempt has been made to obtain missing information; however, no definitive 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 that an intraocular lens (iol) had a white substance attached to the iol.The substance was coming from the 1mtec30 cartridge as the lens traveled down the barrel of the cartridge.The lens remains implanted.There was no patient injury.No additional information was provided to johnson & johnson surgical vision.
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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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Section d10: device available for evaluation?: yes.Returned to manufacturer on: 3/31/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the opened and used cartridge was visually inspected.The review was completed on a nikon smz800 stereo microscope (asset: (b)(4)) at magnifications between 10x and 30x.No physical damage or significant visual flaws was observed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints revealed 1 other complaint has been received for this production order number and no failure was detected.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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Search Alerts/Recalls
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