Model Number NGP680300 |
Device Problem
Obstruction of Flow (2423)
|
Patient Problem
Fluid Discharge (2686)
|
Event Date 01/23/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of birth of patient is unknown.Device manufacture date is unknown.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
|
|
Event Description
|
During a cataract extraction procedure, the surgery center reported wound leakage in the patient¿s left operative eye requiring two sutures to close the wound.A brief description of the event is that during the procedure, the anterior chamber filled with air that created a bubble at the tip.The surgeon¿s comments were of observing a mild change during the procedure and that the wound was not sealing which resulted in sutures to close the wound.The patient outcome is well with 20/20 monovision.
|
|
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 capa-010215.
|
|
Manufacturer Narrative
|
H4: additional info: in initial report, the manufacturer year was not originally available; however, the date is 03/10/2012.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.H3 other text : placeholder.
|
|
Search Alerts/Recalls
|