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 8/4/2019 and 8/17/2018.(b)(4).Device evaluation: the product testing could not be performed as the device 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 review.The product was manufactured and released according to specifications.The search revealed that no similar complaints were received for this production order number.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.
Event or Problem Description
It was reported that the tecnis symfony toric intraocular lens (model zxt375 +15.5 diopter) was explanted from the patient¿s right eye in a secondary procedure because of residual refractive error.There was no incision enlargement, no vitrectomy was performed and no sutures were required.A zxt375 +14.0 diopter was implanted as a replacement.Reportedly, the patient was doing good post lens exchange.The account commented that the explanted lens was discarded at the surgery center.No further information was provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa: 010215.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8413739
• Report Number: 9614546-2019-00214
• Device Sequence Number: 1975801
• Product Code: POE
• UDI-Device Identifier: 05050474606883
• UDI-Public: (01)05050474606883(17)210809
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• 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: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020
• 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: Health Professional
• Device Expiration Date: 08/09/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U155
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 11/10/2020
• 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: 67 YR
• Date Report Sent to FDA: 01/01/2005