MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: if explanted, give date: not applicable, as lens remains implanted.The device is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a clinical study subject was implanted bilateral intraocular lenses (iols) and completed the patient-reported visual symptom questionnaire at the 1 month visit and reported extremely bothered by halos, night driving is difficult; extremely bothered by scattered light, driving; very bothered by poor low light vision, reading in low light.Visual acuity- 20/25 right eye (od); 20/20 left eye (os).Subject reports symptoms as debilitating.However, no intervention planned at this time.Pre-operative bcdva: 20/30 right eye, 20/20 left eye it was learned that the subject returned for a 6-month visit.Monocular uncorrected distance visual acuity (ucdva): 20/40 od, 20/20 os; bcdva: 20/30 od, 20/20 os.The patient reported visual symptom complaints for both eyes (ou) on the questionnaire: subject reported being extremely bothered by halos, worry a lot when driving at night that the halos cover up a car ahead of me when another car is approaching; extremely bothered by starbursts- the patient feels that it is more difficulty to drive at night than before, however can still drive; extremely bothered by sensitivity to light- the patient squints without sunglasses; and extremely bothered by glare- driving at night is more difficult now than before surgery.It was stated that visual symptoms are not debilitating.No surgical intervention planned.This mdr report pertains to the left eye (os).A separate report will be submitted for the right eye (od).

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11387245
• Report Number: 2648035-2021-00036
• Device Sequence Number: 4162736
• Product Code: POE
• UDI-Device Identifier: 05050474605220
• UDI-Public: (01)05050474605220(17)231018
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR