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)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt375 15.0 diopter lens was implanted in the patient''s right eye (od) on (b)(6) 2018.Reportedly, the pre-operative symfony toric calculator recommended a model of zxt375 leaving residual cylinder +0.94 axis 83.Also, ak x 90 was performed for predicted residual cylinder.Intra-operative ocular response analyzer (ora) recommended 15.0 diopter.It was later explanted on (b)(6) 2018 because the patient had residual astigmatism and a flipped axis noted at their office visit with the doctor on (b)(6) 2018.A pre-operative measurement was done again using the symfony toric calculator, which recommended zxt300 with predicted residual cylinder +0.03 axis 61.Intra-operative ocular response analyzer (ora) measurements after removal of original lens recommended 15.5 diopter, but still recommended zxt375.However, the doctor chose a zxt300 15.5 diopter lens as the replacement lens.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to 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 product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7568167
• Report Number: 9614546-2018-00535
• Device Sequence Number: 178863
• Product Code: POE
• UDI-Device Identifier: 05050474606876
• UDI-Public: (01)05050474606876(17)220608
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 08/15/2018
• 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: 06/08/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U150
• 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: 05/07/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 08/15/2018
• 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