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

Model Number	ZXR00
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	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: n/a (not applicable).Lens remains implanted.(b)(4).Device evaluation: the product was not returned to the manufacturing site as it remains implanted; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed no similar complaints were received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient has a zxr00 intraocular lens (iol) implanted in her left (os) eye on (b)(6) 2018.About a month postop, patient informed her surgeon that she is extremely unhappy and that the symptoms of no change in vision, along with blurriness in both eyes at all ranges interfere with her normal daily activities.There is no plan for explant at this time.No further information was provided.The patient has bilateral lens implants.This report represents the left eye.A separate report will be submitted for the right eye.
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: 8787527
• Report Number: 9614546-2019-00612
• Device Sequence Number: 13870095
• Product Code: POE
• UDI-Device Identifier: 05050474579088
• UDI-Public: (01)05050474579088(17)220909
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0195
• 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: 06/14/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/14/2019
• Supplement Report FDA Received Date: 11/13/2020
• 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: Other
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005