Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable, the cartridge is not an implantable device.Section d6b - explant date: not applicable, the cartridge is not an implantable device.Section e1 - telephone number: (b)(6).Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that five (5) additional complaints were received for this po.These five complaints are similar and from two separate accounts.Therefore, no escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
|
It was reported that five (5) lenses were found to be scratched after implantation.The surgeon suspects, that the cartridges are the problem, because the scratches were not visible until the lens was in the eyes of the patients.The lens remains implanted and no further details were provided.This is report 2 out of 5.
|