Additional narrative: note: this mdr report is being submitted due to a retrospective review of complaints associated with a remedial action (recall id number: 91290).Section a2, a3, a4, a5: unknown/ not provided.Section d6a/d6b - not applicable, as this is not an implantable device.Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2022 and (b)(6) 2022.Section h9: johnson & johnson surgical vision (jjsv) has initiated a field action related to the veritas¿ advanced infusion packs (vrt-ai) and veritas¿ advanced fluidics packs (vrt-af) due to the potential for the weld protrusion to be larger than the design specification which could lead to failure during the priming cycle and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during the surgical case.This could result in a delay in surgery and/or longer surgical time, which may result in post-operative ocular sequalae, such as transient corneal edema.Device evaluation: product was returned and evaluated.A visual inspection showed excessive weld gap.The reported event was confirmed.Based on investigation results a product malfunction and product deficiency was confirmed.A nonconformance was initiated to address the weld gap protrusion findings.In addition the peristaltic pump tubing at the top of the cassette was slightly twisted and contacting the top surface of the cassette.The lower drain pump tubing was in contact with the bottom surface of the cassette.Manufacturing record review: a review of the records related to the device was performed.The records showed the device and its components met all specifications prior to being released.Conclusion: as a result of the investigation there is indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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