Model Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Visual Disturbances (2140); Anxiety (2328); Distress (2329)
|
Event Type
Injury
|
Manufacturer Narrative
|
Date of event: unknown, but the best estimate is between may and august 2018.To date the lens remains implanted and therefore not explanted.It was indicated that the device is not returning for evaluation as to date it remains implanted.The serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
|
|
Event Description
|
A patient reported having an intraocular lens (iol) implanted 3 months ago as suggested by her ophthalmologist.The surgery was done to correct the refraction and the patient's expectation was to no longer wear glasses.Reportedly, the patient is disappointed post surgery because she has to still wear glasses and the iol did not correct the refraction as expected.The patient reported having no motivation to the point of giving up practicing physical activities, is completely distressed, and due to anxiety the patient gained almost 10 kilos.No further information was provided.
|
|
Manufacturer Narrative
|
Corrected data: upon further review of the file it was noticed that there is no indication that the symptoms significantly interferes with the patient's life or they are preventing her to performed daily activities.Therefore, no further information will be provided under this manufacturer report number 2648035-2018-01250, as it has now been determined to be not a reportable event.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 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-(b)(4).
|
|
Search Alerts/Recalls
|