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); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, information not provided.If explanted, give date: unknown/not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt150 23.5 diopter intraocular lens (iol) was explanted from the patient¿s left eye due to poor vision.The replacement iol was model zct150 23.5 diopter.Reportedly, there was no injury to the patient, and there were no complications such as incision enlargement, vitrectomy or sutures required.Thru follow-up the following was explained.The patient was diagnosed with ametropia before surgery and was hoping the lens that was to be implanted (zxt150) would improve her vision.After the surgery the patient complained that her vision didn¿t improve and she still had functional limitations.The lens was exchanged for a model zct150.No further information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation, returned to manufacturer on 04/13/2020.Device evaluation: the product was returned to the manufacturing site for evaluation.The iol was not returned in its original package.Visual inspection using magnification was performed on the returned sample.Lens returned cut in two pieces.Loose fibers/particles were observed on lens pieces related the handling of the unit out of a sterile environment.The condition in which the sample returned is consistent with a lens that was implanted and explanted.Due to the conditions of the lens returned, the complaint issue reported could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: 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.
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: 9961001
• Report Number: 2648035-2020-00355
• Device Sequence Number: 16858317
• Product Code: POE
• UDI-Device Identifier: 05050474605275
• UDI-Public: (01)05050474605275(17)231024
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 10/24/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/16/2020; 10/25/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 04/21/2020; 10/30/2020
• 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
• Date Report Sent to FDA: 01/01/2005