Model Number TG85ML |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Endophthalmitis (1835); No Code Available (3191)
|
Event Date 06/27/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
If implanted, give date: not applicable as this is not an implanted device.If explanted, give date: not applicable as this is not an implanted device.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Event Description
|
It was reported that the healon gv pro was used on a patient who experienced endophthalmitis.The reporter stated that they do not feel the cause was johnson and johnson related.As endophthalmitis is not self-resolving then medication is expected to have been administered.Therefore, this event has been assessed as reportable.No further information is available at this time.
|
|
Manufacturer Narrative
|
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search 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.H3 other text : placeholder.
|
|
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 (b)(4) and (b)(4).
|
|
Search Alerts/Recalls
|