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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.(b)(4).An attempt has 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 the patient's first multifocal toric iol implanted in the right eye (od) was perfect.Pre-op -4.50+4.50x95, and post-op -0.25+0.25x95.The second eye, left eye (os) was -6.00+2.50x105 pre-op and +0.50+0.75x180.The patient was reported to be hyperopic with cylinder in flipped axis.Reportedly, the model zxt375 lens was used, with an expectation of residual at 92 degrees.The lens was explanted on (b)(6) 2018 and replaced with a different model iol, zxt300 (16.0 diopter).It is unknown exactly when the visual issues first started.There was no incision enlargement, no vitrectomy and no sutures were required at explant/exchange.There was no patient post-op injury and no complications reported.It was confirmed that the patient was well post-op.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.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.Historical data analysis: the search in complaint history revealed that no similar complaints were received for this production order number.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 and 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 92705
• MDR Report Key: 7437508
• Report Number: 9614546-2018-00354
• Device Sequence Number: 238696
• Product Code: POE
• UDI-Device Identifier: 05050474606920
• UDI-Public: (01)05050474606920(17)220917
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018
• 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: 09/17/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U175
• 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: 03/19/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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
• Date Report Sent to FDA: 01/01/2005