Model Number 1MTEC30 |
Device Problem
Contamination (1120)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: 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.
|
|
Event Description
|
It was reported that the 1mtec cartridge was used and it transferred some ''material'' onto the intraocular lens (iol).It was described as viscous material which occurred during iol delivery into the patient¿s eye.The doctor had to go behind the optic to do irrigation/aspiration to take off the material from the optic.Nevertheless, the lens remains implanted.And there was no visual issue post-op.No other information was provided.
|
|
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.
|
|
Manufacturer Narrative
|
Additional information: section d10: device available for evaluation: yes section d10: returned to manufacturer on: 3/2/2020 section h3: device returned to manufacturer: yes device evaluation: the opened and used cartridges was visually inspected.No physical damage or significant visual flaws were observed.Based on the sample evaluation there is no indication of a product malfunction.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 complaints were received from 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.
|
|
Search Alerts/Recalls
|