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

Model Number	ZXT300
Medical Device Problem Codes	Arcing (2583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, an exact date was not provided, however, the patient stated it was a few weeks after implant.If explanted, give date: not applicable, as the lens remains implanted.However, there is a planned explant to be performed on (b)(6) 2018.(b)(4).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, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt300 18.0 diopter lens was implanted in the patient's left eye (os) on (b)(6) 2017.Post-operatively, the patient complained of intolerable, overwhelming, and debilitating glare, including halos, concentric circles, and starbursts.Patient was asked about the onset date of the symptoms, she did not remember when it started, maybe a couple weeks later, post implant.Reportedly, the lens is planned to be explanted and exchanged on (b)(6) 2018, no additional information was provided.
Additional Manufacturer Narrative
Additional information: based on new information received, patient experienced blurry vision, rings in vision and starburst.Intraocular lens on left eye (os) was replaced with zct300 17.5 diopter.An incision enlargement to 2.8mm was performed along with one suture at explant, (b)(6) 2018.The following sections have been updated accordingly: if explanted; give date: (b)(6) 2018.Device code 2583.Patient code 3191 - starburst.Patient code 3191 - planned explant to explant/iol exchanged.Patient code 3191 - incision enlargement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7463166
• Report Number: 9614546-2018-00395
• Device Sequence Number: 333339
• Product Code: POE
• UDI-Device Identifier: 05050474606340
• UDI-Public: (01)05050474606340(17)210706
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2018
• Report Date (Section F): 01/01/2005

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: Physician
• Device Expiration Date: 07/06/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 05/23/2018; 07/25/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 06/18/2018; 08/23/2018
• 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: Required Intervention
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005