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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown/not provided, but best estimate is between (b)(6) 2019 and (b)(6) 2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that patient is post radial keratotomy (rk) and has a panoptix toric in the other eye.The patient is very unhappy with the symfony intraocular lens (iol) in the right eye.Through follow-up, it was learned that the patient had blurred vision at distance uncorrected.There was no loss of 2 or more lines best spectacle corrected visual acuity(bscva).Pre op va: 20/70 sc 20/40 cc post rk (remote) and post operative visual acuity (va): 20/60 sc 20/25-1 cc near j5 sc.Additional information provided that the lens was explanted.No additional information was provided.
Additional Manufacturer Narrative
Section d10: device available for evaluation? yes.Returned to manufacturer on: 10/21/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received in a specimen cup.Visual inspection under magnification revealed lens damage and viscoelastic residue on the optic body and haptic, which is consistent with a lens that was handled during explant.The lens was cleaned, and lens damage was still observed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.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 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: 10498030
• Report Number: 9614546-2020-00376
• Device Sequence Number: 2476370
• Product Code: POE
• UDI-Device Identifier: 05050474579132
• UDI-Public: (01)05050474579132(17)231010
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2020
• 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: 10/10/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/25/2020; 11/02/2020
• Initial Report FDA Received Date: 09/05/2020
• Supplement Report FDA Received Date: 10/29/2020; 11/30/2020
• 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