[183681378]
Age/date of birth: unknown, information not provided. Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2019. If explanted, give date: not applicable, remains implanted in the eye. Device evaluation: product testing could not be performed because the product was not returned as it remains implanted. The reported complaint was not confirmed. Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported. A search revealed no additional investigation requests for this production order number. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. Attempts have been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183681379]
It was reported that patient underwent cataract surgery in (b)(6) 2019 for her both eyes. After the surgery she is experiencing halos and starburst. Her vision is good besides and uses glasses for close up vision. She reported this to her surgeon in (b)(6) 2019 and was told to see him next year. She saw the doctor in (b)(6) 2020 and a night test was done to evaluate her vision. However, she said the lights they used were not indicative of what she actually sees when she? S driving. She stated that the halos and starbursts occur around any light source. It is severe enough to where she has stopped driving at night, out of concern she could easily get into an accident. In addition, she was told there was no scar tissue and that lasik would not help. She was prescribed glasses to help with the issue, but it doesn? T work. Her doctor didn? T advise her about how to improve the issue, but stated it is better than a cataract, and that he? D see her next year. Additional information was received and it was learnt that doctor prescribed her with pilocarpine eye drops which lead to migraine and pain. It although temporarily helped with halos however migraine was very bad. She added that she cannot drive at all at night as the halos and starburst is very bad at night. Her day vision is good. She saw first symptom right away after the surgery when the patch was opened, on requesting information if the doctor discussed any plan for any intervention she stated that per doctor it is so risky to do anything so he has not yet discussed anything. This event will capture information for patient? S right eye. A separate report is being submitted for patient? S left eye. No further information provided.
Patient Sequence No: 1, Text Type: D, B5