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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Retinal Detachment (2047); Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date the lens remains implanted in the eye.It was indicated that the lens remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, (labeling*), complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the tecnis symfony multifocal intraocular lens (model zxr00, +13.5 diopter) was implanted into the patient's left eye on (b)(6) 2017.Reportedly, there was a capsule tear and a vitrectomy was performed.Retinal detachment occurred 4 days post op.The lens remains implanted.No further information was provided.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7600305
• Report Number: 9614546-2018-00582
• Device Sequence Number: 1623286
• Product Code: POE
• UDI-Device Identifier: 05050474591714
• UDI-Public: (01)05050474591714(17)220118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 01/18/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/14/2018
• 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: 55 YR