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); Visual Impairment (2138); No Code Available (3191)
Date of Event	01/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as to date the lens remains implanted.(b)(4).It was indicated that the device is not returning for evaluation as it remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation 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 reported that the patient had a bilateral symfony intraocular lens implantation.Refraction pre-op was -5.00 + 0.25 x 175 degrees os (left eye) vision 20/25 in ambient light and 20/100 in medium glare conditions.A zxr00 lens +11.5 diopter was implanted os on (b)(6) 2017 visual acuity os on (b)(6) 2017 was 2/20.Near vision not recorded due to dilated pupil.On (b)(6) 2017: uncorrected distance visual acuity (udva) os was 20/25 - near vision j6.The near vision was not sharp.Corrected visual acuity was 20/20 - j1 ou (both eyes) with -0.75 + 0.50 x 125 os.Early pco (posterior capsule opacification) was noted od > os.Yag (yttrium aluminium garnet) laser performed to improve vision.On (b)(6) 2017 - patient glared to 20/100 both eyes.On (b)(6) 2017 - patient commented that she was unable to read and needed reading glasses.On (b)(6) 2017 - uncorrected visual acuity os 20/25 - (very blurry) distance and j6 near.On (b)(6) 2017 - uncorrected visual acuity os 20/25 - j6 , refraction os -0.50 + 0.50 x 135 - 20/20 - j4.On (b)(6) 2017 lasik (laser assisted in-situ keratomileusis) performed to correct small refractive error.On (b)(6) 2017 uncorrected visual acuity os 20/40 , epithelial defect was present os.The left eye developed an epithelial erosion requiring a stromal puncture.Patient also developed a recurrent uveitis that was eventually treated and resolved.On (b)(6) 2018 - uncorrected visual acuity os 20/40 - j5 -0.50 + 0.50 x 180 (no improvement).The surgeon commented that the patient will be returning for a follow up later in (b)(6).Very unhappy with near vision.Distance vision is good.No further information was provided.This report is to record the lens implanted in the left eye.
Additional Manufacturer Narrative
Additional information: it was learnt that patient¿s distance vision improved to 20/20 sans correction (sc).Patient¿s near vision remains poor in both eye.This report is for patient¿s left eye.No further information provided.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7653694
• Report Number: 9614546-2018-00623
• Device Sequence Number: 16189024
• Product Code: POE
• UDI-Device Identifier: 05050474591677
• UDI-Public: (01)05050474591677(17)211115
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018
• 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: Physician
• Device Expiration Date: 11/15/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/02/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 06/30/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005