Model Number ZCT300 |
Device Problem
Unintended Movement (3026)
|
Patient Problems
Dizziness (2194); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Event Description
|
It was reported that a zct300 19.5 diopter intraocular lens (iol) was implanted in the patient's left eye (os) on (b)(6) 2018.It was later explanted on (b)(6) 2018 because the patient felt off balance/dizzy post-operatively.It was also reported that the lens rotated, but the degree of rotation post-operatively is unknown.The replacement lens was the same model, but different diopter (19.0).No additional information was provided.
|
|
Manufacturer Narrative
|
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.
|
|
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
|