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 Impairment (2138); Visual Disturbances (2140); No Code Available (3191)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: explant was planned.However not yet confirmed.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon was planning to explant a tecnis symfony toric multifocal intraocular lens (model zxt150, +13.0 diopter) from patient¿s right eye in secondary procedure because of patient experiencing cloudy vision, trouble with distance and near vision.At the time of this report, the lens has not yet been explanted.No further information provided.
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: 7521063
• Report Number: 9614546-2018-00475
• Device Sequence Number: 19192078
• Product Code: POE
• UDI-Device Identifier: 05050474605060
• UDI-Public: (01)05050474605060(17)220412
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018
• 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: 04/12/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U130
• 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: 04/18/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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: 72 YR
• Date Report Sent to FDA: 01/01/2005