Model Number ZCT150 |
Device Problem
Unintended Movement (3026)
|
Patient Problem
No Code Available (3191)
|
Event Date 10/17/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Age / date of birth: unknown / not provided.If implanted; give date: unknown / not provided.If explanted; give date: not applicable as the lens remains implanted.(b)(6).(b)(4).Device evaluation: the product testing could not be performed as the lens remains implanted.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search in complaint system revealed that no similar complaints were received for 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.
|
|
Event Description
|
It was reported that model zct intraocular lenses (iols) were implanted in a male patient's both (ou) eyes.During post-operative examination, both lenses were found to have rotated 20-30 degrees clockwise away from the original axis and the visual (va) dropped.The lenses were repositioned in a secondary procedure on (b)(6) 2019.It was noted that sutures were required and no other surgical interventions such as vitrectomy or incision enlargement were needed.This report pertains to the lens in the patient's left eye (os).A separate report will be submitted for the patient's right eye (od).
|
|
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-(b)(4) and capa-010215.
|
|
Search Alerts/Recalls
|