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	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The intraocular lens (iol) is not returning for evaluation as it is discarded; 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 zxt150 intraocular lens (iol) was explanted from patient's left eye (os).There was a patient contact.Per follow-up, patient had cataract surgery with optiwave refractive analysis (ora) on (b)(6) 2018 and a symfony lens implanted.The ora called for a zxt150 22.5, so that¿s what was implanted.When patient came back for follow ups, he complained of blurred vision in that eye.Upon refraction, the patient was still found to have 1.50 residual cylinder.Patient's pre-existing condition¿ hypertension (htn), heart disease, gastroesophageal reflux disease (gerd), osteoarthritis, gout, diverticulosis, and atrial fibrillation.Pre-operation best visual acuity (bva) ¿ 20/40 -2, post-operation bva ¿ 20/30 -2, the patient is only one and half (1.5) weeks post-op.The original iol has been discarded by surgery center.The original incision was reentered, but not enlarged.There were no other injuries sustained.No additional information provided.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7657156
• Report Number: 9614546-2018-00632
• Device Sequence Number: 13493632
• Product Code: MFK
• UDI-Device Identifier: 05050474605312
• UDI-Public: (01)05050474605312(17)220504
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 05/04/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 07/02/2018
• 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: 73 YR