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	Therapeutic Effects, Unexpected (2099); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 reported that a female patient was implanted with a symfony intraocular lens (iol), but she developed blurry near vision.Distance visual acuity was great, but the patient has poor intermediate/near visual acuity.J10 is the best that she had ever measured.The patient did not have cataracts pre-op, the initial procedure was a clear lens exchange (clear lens extraction).A yttrium-aluminum garnet (yag) capsulotomy was conducted and dry eye treated.Follow-up confirmed the yag capsulotomy was done following surgery due to a posterior capsule opacification that was treated with a laser.The customer thought this would solve the difficulty with the patient¿s near vision and thus felt this was the best treatment for her at the time.Unfortunately, it didn¿t help and the iol could no longer be explanted.The patient has dry eye which they try to treat to also see if this was why the patient didn¿t achieve good near/intermediate vision from the symfony iol.Unfortunately, this did not resolve her symptoms either.Nevertheless, the patient has great distance vision post-op.The goal was to reduce the patient¿s dependence on readers but this did not happen.Pre-operative uncorrected visual acuity 20/300 j1.Visual acuity post-operative 20/20 j10.No other information was provided.

• 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: 11092900
• Report Number: 9614546-2020-00544
• Device Sequence Number: 836905
• Product Code: POE
• UDI-Device Identifier: 05050474579040
• UDI-Public: (01)05050474579040(17)230702
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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: 07/02/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• 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
• Patient Age: 45 YR