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

Model Number	ZXR00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted as the lens malfunctioned.Reportedly, there was no vitrectomy, incision enlargement or sutures required.Another lens, same model and a 22.0 (smaller) diopter was implanted as a replacement.The patient is doing well.The customer was unable to provide any more information.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information device available for evaluation? yes.Returned to manufacturer on: 6/4/19.Device returned to manufacturer? yes.Device evaluation: a visual inspection of the product showed traces of ophthalmic viscoelastic device (ovd) on its surface, as well as a cut through the optic body, most probably to aid in explanting the lens.Further inspection under magnification did not reveal any damage or defect.Due to the condition of the return, further analysis is not possible.The reported issue could not be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no additional complaints for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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
• 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: 8684427
• Report Number: 3011852734-2019-00123
• Device Sequence Number: 19358597
• Product Code: POE
• UDI-Device Identifier: 05050474579156
• UDI-Public: (01)05050474579156(17)230911
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 11/12/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 10/25/2020
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/16/2019; 11/12/2020
• 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