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	Dry Eye(s) (1814); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If explanted, give date: not applicable, as lens remains implanted.(b)(4).A failure analysis of the complaint device cannot be completed as product remains implanted; therefore, a failure analysis of the complaint device cannot be completed.However, a review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that a female patient status post (s/p) lasik, implanted with a symfony intraocular lens (iol), in the second eye (left eye (os), post-op day one (pod 1), visual acuity (va) was 20/30 and j1.Then post-op week one (pow 1) the patient¿s va dropped to 20/125.After treating for dry eyes, she is now at 20/70 with j1.Her distance has decreased but her cpu and near are great.She has halos that are getting better.Also noted that her surface was much better, but distance vision and starbursts continue to be a problem.Her first eye is doing great s/p lasik in the past with symfony placement.Through follow-up additional information was provided for the left eye.Pre-op data +2.00 +0.75 x 178 distance 20/30, near j1, mild dry eyes, retina exam and optical coherence tomography (oct) macula were stable.Post-implant data: pod 1 distance sans correction (sc) 20/30, near sc j1 post-op week one (pow 1) distance sc 20/125.Pin hole (ph) to 20/30, near sc j2.Pt was dilated and no cystoid macular edema (cme) noted but surface appeared more irritated - discussed tears post-op month one (pom 1) distance sc 20/100, ph to 20/40, near sc j1.Manifest refraction (mrx) os +1.00 sphere (sph) add +1.50 - distance with correction (cc) 20/70, near cc j1 at this visit, the patient noted large starbursts.Dilated fundus examination (dfe) showed again no cme but surface continued to be irritated resulting in a decreased view to the fundus.The patient was asked to use refresh celluvisc and steroid drops.Pom 2 distance sc 20/70, ph 20/30 ¿ patient improving, continued same management pom 3 distance sc 20/70, ph 20/30, near sc j1 pom 4 distance sc 20/80, ph 20/50, near j1 mrx os -1.00 +0.50 x 159 add +1.50 distance cc 20/50, near cc j1 patient surface was much better but distance vision and starbursts continue to be a problem.No further information provided.

• 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: 11085474
• Report Number: 9614546-2020-00541
• Device Sequence Number: 11513201
• Product Code: MJP
• UDI-Device Identifier: 05050474605244
• UDI-Public: (01)05050474605244(17)240312
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2020

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: 03/12/2024
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/29/2020
• 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