|
Model Number G301 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Visual Impairment (2138)
|
Event Type
Injury
|
Event Description
|
It was reported, that patient was overcorrected with no more than 1 diopter.And an enhancement was performed.No loss of best corrected visual acuity (bcva).And no patient injury was reported.No additional information was provided.
|
|
Manufacturer Narrative
|
Section a2 : the accurate age wasn't provided, but the patient's age is 40 years old and older.Device evaluation: a field service engineer (fse), visited site to service the system and found no issues in relationship to the overcorrection.The system is performing to specification.An application support manager (asm), also visited site and reported that the overcorrection was a result of doctor's training.Asm provided additional training and recommendations to avoid getting overcorrections.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.
|
|
Manufacturer Narrative
|
Additional information: application support manager (asm) spoke with doctor regarding the procedures in which enhancements were performed.Doctor reported that all but one were bilateral enhancements.He was not able to provide the dates or patient demographics.No additional information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Manufacturer Narrative
|
Correction: h4: in initial report, the manufacturer date provided was inadvertently reported as july 1, 2021, however the correct date is july 24, 2021.Additional information: manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
|
|
Search Alerts/Recalls
|
|
|