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	Halo (2227); No Code Available (3191)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: not applicable as the iol remains implanted in the patient's eye.It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s eye therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zxr00 16.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye) on (b)(6) 2019.At the 3-month study visit on (b)(6) 2019, subject reported that she was moderately bothered by poor light vision but didn¿t report any issues with glare or halos at that time.At the 4-month study visit, (b)(6) 2019, subject stated on the patient-reported visual symptom questionnaire (prvsq) that she avoids driving at night due to glare and halos and she confirmed that symptoms are debilitating to daily living.Doctor indicated that the visual symptoms are iol related.It was reported the patient exited from the study following (b)(6) 2019 study visit and there is no additional treatment other than observation.No additional information was provided to johnson & johnson surgical vision.This report is for the left eye.A separate report will be submitted for the right eye.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Labeling review: a search of complaints revealed that one (01) similar complaint was received for this production order number.There was no product deficiency identified.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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 (b)(4) 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: 8964267
• Report Number: 9614546-2019-00819
• Device Sequence Number: 13978025
• Product Code: POE
• UDI-Device Identifier: 05050474579026
• UDI-Public: (01)05050474579026(17)230228
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 02/28/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0165
• 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: 08/09/2019
• Supplement Date Received by Manufacturer: 09/18/2019; 10/25/2020
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/02/2019; 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: Other
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005