Model Number 1MTEC30 |
Device Problems
Difficult or Delayed Positioning (1157); Positioning Failure (1158)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/02/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.Lot #: unknown, was not provided.Expiration date: unknown, since lot number was not provided.Udi#: unknown since product lot number was not provided.Device manufacture date: unknown, as the lot number of the device was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Event Description
|
Reportedly, the zct450 lens was tight and difficult to inject into the patient's eye as it was stuck in 1mtec30 cartridge.It was only partially implanted with the front haptic into the patient's eye.Insertion was aborted and lens pulled out of the eye.There was no injury to the patient and no other measures were done.No additional information provided.
|
|
Manufacturer Narrative
|
Device available for evaluation? yes.Returned to manufacturer on: 8/07/2018.Device returned to manufacturer? yes.Device evaluation: the 1mtec30 cartridge was not returned it its original package.Visual inspection using microscope magnification was performed: residues of lubricant material were observed on cartridge.The cartridge tip section was observed slightly deformed.The lens was also observed damaged and stuck in cartridge.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported was verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing record review: a manufacturing record review could not be performed as no lot number was provided.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|