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Model Number 1MTEC30 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: exact date unknown, not provided.Best estimate (b)(6) 2019.If implanted; if explanted; give date: n/a (not applicable).The cartridge is not an implantable device.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 the doctor is seeing an increase in plaques coming from the cartridges at time of lens injection.Maybe 50% of recent cases.The doctor shared two (2) specific case images that occurred recently with a flake of material that goes in from the injector with the lens.It was also stated that the debris is easy to take out by irrigation and aspiration (ia).Follow-up noted that they have had this issue before (approx.2 years ago) and it went away from some time and manifested again around the beginning of summer, but no exact dates or other specific information provided.It was learned that all patients had no adverse events and one of the doctor¿s colleagues did leave it in the eye and the patient was fine.No other information was provided.2 mdr reports are required, one for each case reported.This mdr is to capture case#2.Another mdr is submitted to capture case #1.
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Manufacturer Narrative
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Device available for evaluation; returned to manufacturer on: 10/29/2019.Device evaluation: the sample was evaluated by a principal engineer and no damages or flaws were observed.The complaint reported was not verified and no product deficiency was identified.In addition, photos were provided and were reviewed.The photo shows as per customer information two cases with the flake (debris/particle) sitting on posterior aspect of the lens.However, the origin or the source of the material is unknown.Based on the sample evaluation that was returned, no damages were identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional investigations were received related to this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 nr-0148919 and capa-010215.
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Search Alerts/Recalls
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