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); No Code Available (3191)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.(b)(4).Device evaluation: product evaluation was not performed because per the initial report the lens is still implanted in the patient's eye.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaint was received from this production order.However, there is one complaint but although the complaint issues are related and pertain to the same patient, this complaint could not be confirmed because the product is still implanted.No product deficiency and nor malfunction was identified, therefore no escalation is required conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that at the 6 month visit a patient who had bilateral implants became moderately bothered by halos- driving; moderately bothered by starbursts- uncomfortable driving; moderately bothered by multiple or double vision- watching tv; moderately bothered by glare related to scattered light- judgement in driving; extremely bothered by poor low light vision- inside the home.Although, the monocular uncorrected distance visual acuity (ucdva) - right eye (od) 20/25; left eye (os) 20/40.Monocular are best corrected visual acuity (bcdva) ¿ od 20/20; os 20/20 and no intervention planned.No other information was provided.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: 10902115
• Report Number: 9614546-2020-00500
• Device Sequence Number: 2758201
• Product Code: POE
• UDI-Device Identifier: 05050474605084
• UDI-Public: (01)05050474605084(17)211211
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/24/2020

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: 12/11/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/25/2020
• 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: 71 YR