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	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If explanted; give date: n/a (not applicable).Lens remains implanted.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 additional complaint has been received from 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 a clinical study subject had tecnis symfony intraocular lens (iol) bilateral implants.A model zxr00 lens was implanted in the subject's left (os) eye on (b)(6) 2019.At the three months visit on (b)(6) 2019, the subject reported being slightly bothered with difficulty driving due to halos, starbursts and glare, and being moderately bothered by low light vision, causing difficulty reading.At this visit the patient¿s monocular best corrected visual acuity (bcdva) was 20/20 right eye (od) and 20/32 os, with mild posterior capsular opacification (pco) in the os and trace in od.The subject also mentioned to the surgeon that she has been having these symptoms since surgery.Her pre-op visual acuity was: uncorrected distance vision (ucdv) 20/25 os, best corrected distance vision (bcdv) 20/15 os.The subject returned for a 4-month study visit on (b)(6) 2019, and reported the following symptoms: slightly bothered by halos causing difficulty with driving; moderately bothered with starbursts causing difficulty with driving; very bothered with multiple/double vision causing difficulty watching television; very bothered by glare causing difficulty driving; and moderately bothered by poor low light vision, causing difficulty with reading.Monocular best-corrected distance visual acuity at this visit was 20/20 od, and 20/40 os ¿ the poor vision os was caused by double vision.Following this visit the site planned to do a photorefractive keratectomy (prk) enhancement on the left eye only following study exit.The prk enhancement took place on (b)(6) 2019.The patient returned on (b)(6) for a one-month post-prk visit.The best corrected distance visual acuity (bcdva) for the left eye at this visit was 20/25.No additional intervention is anticipated.
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-(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: 9604682
• Report Number: 2648035-2020-00065
• Device Sequence Number: 2573414
• Product Code: POE
• UDI-Device Identifier: 05050474579118
• UDI-Public: (01)05050474579118(17)231213
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020
• 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: 12/13/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0210
• 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: 12/19/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/18/2020
• Supplement Report FDA Received Date: 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
• Date Report Sent to FDA: 01/01/2005