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	Blurred Vision (2137); No Code Available (3191)
Date of Event	02/07/2019
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 zxt150 intraocular lens (iol) was explanted due to the patient experiencing blurry vision in the right eye.The explanted iol was replaced with a zcb00 iol.There was no report of incision enlargement, vitrectomy or sutures that were performed.The patient was well post-op.No other information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on: 9/4/2019.Device evaluated by manufacturer.Device evaluation: sample was received.The zxt150 lens was not received in its original package.Visual inspection revealed that the lens returned was cut in two pieces.Loose fibers/particles were observed on lens pieces related the handling of the unit out of a sterile environment.Residues of lubricant material was observed on lens pieces.No damage was observed to the haptics.The complaint issue reported could not be verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search on the complaint system performed revealed no additional investigation requests for this purchase order (po) number.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: 8968376
• Report Number: 2648035-2019-00974
• Device Sequence Number: 2563146
• Product Code: POE
• UDI-Device Identifier: 05050474605220
• UDI-Public: (01)05050474605220(17)231030
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted 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): 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: 10/30/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/06/2019; 10/25/2020
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 09/27/2019; 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: 71 YR
• Date Report Sent to FDA: 01/01/2005