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	Halo (2227); No Code Available (3191)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: if explanted, give date: not applicable, as lens remains implanted in the patient's ocular dexter (right eye).(b)(4).Device evaluation: product testing could not be performed because the product was not returned as the lens remains implanted in the patient's ocular dexter (right eye).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.Historical data analysis: a search revealed that no similar complaints for this production order number have been received.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.
Event or Problem Description
It was reported at the 3-month study visit zxt150 21.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2019.Od monocular best corrected distant visual acuity (bcdva) at 3-month visit was reported as 20/16 and preop bcdva was 20/25.It was reported the patient is extremely bothered by halos, starbursts, and glare, causing difficulty driving at night.The patient will receive a lipiflow treatment per the study protocol, will return in 4-6 weeks for a follow-up visit, and no other treatment is planned at this time.At the four (04) month study visit, subject reported extreme halos and starbursts, moderate bother with glare, all of which caused difficulty with driving, and moderate bother with multiple or double vision, causing them to blink a lot while reading.The monocular bcdva for this visit was 20/16 od.No further intervention was scheduled at the time of the visit.This was the final study visit for this subject, so we will not receive any more updates unless an intervention takes place.The patient has bilateral lens implants.This report captures the iol implanted in the patient's ocular dexter - right eye.A separate report will be filed for the patient's ocular sinister (left eye).No additional information was provided to johnson & johnson surgical vision.
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: 9289561
• Report Number: 9614546-2019-01035
• Device Sequence Number: 2311146
• Product Code: MFK
• UDI-Device Identifier: 05050474605237
• UDI-Public: (01)05050474605237(17)220919
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• 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: 09/19/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U215
• 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: 10/18/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 11/11/2020
• 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: 65 YR
• Date Report Sent to FDA: 01/01/2005